Suture deployment of prosthetic heart valve

ABSTRACT

A method for delivering a prosthetic valve to a native annulus of a heart can include inserting a delivery apparatus into a patient&#39;s body, advancing the delivery apparatus to an implantation location within the native annulus, retracting a delivery sheath of the delivery apparatus relative to the prosthetic valve to expose the prosthetic valve from a distal end of the delivery sheath, and after the prosthetic valve is exposed from the delivery sheath, expanding the prosthetic valve from a radially compressed state to a radially expanded state by reducing axial tension on a first end and a second end of the prosthetic valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/366,959, filed Dec. 1, 2016, which claims the benefit of U.S.Provisional Patent Application No. 62/262,307, filed Dec. 2, 2015, bothof which are incorporated by reference herein.

FIELD

The present disclosure relates to implantable, expandable prostheticdevices and to methods and delivery assemblies for such prostheticdevices.

BACKGROUND

The human heart can suffer from various valvular diseases. Thesevalvular diseases can result in significant malfunctioning of the heartand ultimately require repair of the native valve or replacement of thenative valve with an artificial valve. There are a number of knownrepair devices (e.g., stents) and artificial valves, as well as a numberof known methods of implanting these devices and valves in humans.Because of the drawbacks associated with conventional open-heartsurgery, percutaneous and minimally-invasive surgical approaches aregarnering intense attention. In one technique, a prosthetic device isconfigured to be implanted in a much less invasive procedure by way ofcatheterization. For example, collapsible transcatheter prosthetic heartvalves can be crimped to a compressed state and percutaneouslyintroduced in the compressed state on a catheter and expanded to afunctional size at the desired position by balloon inflation or byutilization of a self-expanding frame or stent.

A challenge of implanting a self-expanding prosthetic valve via acatheterization is control of the expansion of the prosthetic valve asthe prosthetic valve is deployed from a distal end of a deliveryapparatus (i.e., the end of the apparatus that is advanced into apatient's heart) during the implantation procedure. Typically, aself-expanding prosthetic valve expands rapidly when it is exposed froma delivery cylinder or sheath. The rapid expansion can cause theprosthetic valve to migrate or “jump” from a desired deployment positionwithin the patient's heart. As such, the prosthetic valve mustsubsequently be repositioned to the desired deployment position.

Another challenge of self-expandable prosthetic valves includesrepositioning and/or retrieving the prosthetic valve once it is expandedto the functional size. Repositioning the prosthetic valve can berelatively more difficult in the expanded, functional state because theincreased radial profile of the prosthetic valve can cause theprosthetic valve to engage the native anatomy (e.g., the native annulus)of the patient's heart, which can interfere or prevent the prostheticvalve from moving freely within the patient's heart. Retrieving theprosthetic valve can be relatively more difficult once the prostheticvalve is expanded because it can be difficult to exert sufficient radialforce on the prosthetic valve to cause it to radially compress so thatit can be retracted into a delivery cylinder.

An additional challenge is that about fifty percent of self-expandingprosthetic valves require a balloon post-dilation procedure to expandthe prosthetic valve to its nominal diameter and/or to reduceparavalvular leakage. This additional procedure can add undesirablesteps and thus time to an implantation procedure.

Thus, there is a continuing need for improved transcatheter prostheticdevices and delivery apparatuses for implanting such devices.

SUMMARY

Embodiments of improved prosthetic implant delivery assemblies aredisclosed herein, as well as related methods, apparatuses, and devicesfor such assemblies. In several embodiments, the disclosed assembliesare configured for delivering replacement heart valves into a heart of apatient. The disclosed assemblies, apparatuses, and methods can, forexample, improve a physician's ability to control the expansion,repositioning, and/or retrieval of a prosthetic implant during animplantation procedure.

In one representative embodiment, a delivery assembly comprises anannular stent having a first plurality of apices spacedcircumferentially around a first end portion of the stent, a secondplurality of apices spaced circumferentially around a second end portionof the stent, and an intermediate portion disposed between the first andthe second end portions, wherein the stent is configured to radiallyexpand and axially foreshorten from a first state to a second state andto radially compress and axially elongate from the second state to thefirst state, an elongate shaft disposed radially within and extendingaxially through the stent and having a first manifold coupled to theshaft distal to the first end of the stent, wherein the first manifoldhas a first plurality of openings, a second manifold located proximal tothe first manifold of the shaft, wherein the second manifold has asecond plurality of openings, a first plurality of sutures extendingthrough at least some of the second openings of the second manifold,through the first openings of the first manifold, and through or aroundthe first plurality of apices of the stent, wherein the first pluralityof sutures is releasably coupled to the stent and configured such thatincreasing tension of the first plurality of sutures causes the firstplurality of apices of the stent to radially converge, and a secondplurality of sutures extending through at least some second openings ofthe second manifold and through or around the second plurality of apicesof the stent, wherein the second plurality of sutures is releasablycoupled to the stent and configured such that increasing tension of thesecond plurality of sutures causes the second plurality of apices of thestent to radially converge, wherein the intermediate portion of thestent can radially expand and axially foreshorten when the first and thesecond pluralities of apices radially converge.

In some embodiments, a sheath which can be advanced distally over thestent to retain the stent in the first state and retracted proximallyrelative to the stent to permit radial expansion of the stent from thefirst state to the second state, wherein after the entirety of the stentis deployed from the sheath, the first and the second plurality ofapices of the stent can be radially converged, and the sheath can beadvanced distally back over the stent to cause the stent to radiallycollapse to the first state as it is recaptured by the sheath.

In some embodiments, the first and the second plurality of sutures areconfigured to be independently movable relative to each other. In someembodiments, the second plurality of openings of the second manifold isan inner set of openings and an outer set of openings, the inner set ofopenings being spaced radially inward from the outer set of openings,and wherein the first plurality of sutures extend through the inner setof openings of the second manifold, and the second plurality of suturesextend through the outer set of openings of the second manifold.

In some embodiments, the shaft is a first shaft, and the deliveryassembly further comprises a second shaft to which the second manifoldis coupled. In some embodiments, the first shaft is a nose cone shaftwhich extends coaxially through the second shaft, and a nose cone ismounted on a distal end of the nose cone shaft. In some embodiments, thefirst manifold and the second manifold are configured to be axiallymovable relative to each other.

In some embodiments, the delivery assembly is configured such thatincreasing a spacing between the first manifold and the second manifoldcauses the intermediate portion of the stent to axially elongate and toradially compress. In some embodiments, the delivery assembly isconfigured such that decreasing the spacing between the first manifoldand the second manifold causes the intermediate portion of the stent toaxially foreshorten and to radially expand. In some embodiments, thestent is configured to be self-expandable from the first state to thesecond state. In some embodiments, the delivery assembly furthercomprises at least one apex guide mounted on a suture of the firstplurality of sutures or the second plurality of sutures.

In another representative embodiment, a delivery apparatus for aprosthetic implant comprises an elongate first shaft, a first sutureguide coupled to the first shaft, an elongate second shaft, and a secondsuture guide coupled to the second shaft, wherein the first shaftextends coaxially through the second shaft and the second suture guide,and the first suture guide is disposed distal to the second sutureguide, and wherein the first suture guide and the second suture guideare configured to be axially movable relative to each other.

In some embodiments, the first shaft is a nose cone shaft. In someembodiments, the delivery apparatus further comprises a sheath, whereinthe first and the second suture guides are disposed radially within thesheath when delivering the prosthetic implant to an implantationlocation, and the first and the second suture guides are exposed fromthe sheath when implanting the prosthetic implant at the implantationlocation.

In another representative embodiment, a method for delivering aprosthetic valve to a native annulus of a heart is provided. The methodcan comprise inserting an elongate delivery apparatus into a patient'sbody, advancing the delivery apparatus to an implantation locationwithin the native annulus, retracting a delivery sheath of the deliveryapparatus relative to the prosthetic valve to expose the prostheticvalve from a distal end of the delivery sheath, and after the prostheticvalve is exposed from the delivery sheath, expanding the prostheticvalve from a radially compressed state to a radially expanded state byreducing axial tension on first and second ends of the prosthetic valve.

In some embodiments, reducing axial tension on the first end of theprosthetic valve precedes reducing tension on the second end of theprosthetic valve. In some embodiments, reducing axial tension on thefirst end of the prosthetic valve and reducing tension on the second endof the prosthetic valve occur simultaneously.

In some embodiments, reducing axial tension on the first and second endsof the prosthetic valve comprises reducing tension on a plurality ofsutures of the delivery apparatus. In some embodiments, reducing axialtension on the first and second ends of the prosthetic valve comprisesmoving a first manifold of the delivery apparatus axially proximallytoward a second manifold of the delivery apparatus.

In some embodiments, the radially expanded state of the prosthetic valveis a first radially expanded state, and the method can further compriseexpanding the prosthetic valve from the first radially expanded state toa second radially expanded state by radially converging the first andsecond ends of the prosthetic valve and axially compressing the firstand second ends of the prosthetic valve by moving the first manifold ofthe delivery apparatus axially proximally toward the second manifold ofthe delivery apparatus, wherein the stent is radially larger in thesecond radially expanded state than in the first radially expandedstate. In some embodiments, the method can further comprise radiallycompressing the prosthetic valve by moving the first manifold of thedelivery apparatus axially distally away from the second manifold of thedelivery apparatus.

In another representative embodiment, a delivery assembly comprises anannular frame and a delivery apparatus. The annular frame includes afirst plurality of apices spaced circumferentially around a first endportion of the frame, a second plurality of apices spacedcircumferentially around a second end portion of the frame, and anintermediate portion disposed between the first and the second endportions wherein the frame is configured to radially expand and axiallyforeshorten from a first state to a second state and to radiallycompress and axially elongate from the second state to the first state.The delivery apparatus includes an elongate shaft, a suture guidecoupled to a distal end portion of the shaft, suture loops coupled tothe suture guide, apex guides coupled to the suture loops, and adelivery cylinder that is coaxial and axially movable relative to theshaft, wherein the delivery cylinder is configured to retain the framein the first state when the frame is disposed radially within thedelivery cylinder, wherein the frame is releasably coupled to the sutureguide by the suture loops which extend through respective apex guidesand wrap around at least some of the first apices of the frame, whereinthe apex guides are configured to prevent the first apices of the framefrom snagging on a distal end of the delivery cylinder when the frame isin the second state and is being retrieved into the delivery cylinder.

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a distal end portion of a prosthetic implantdelivery assembly with a prosthetic heart valve in a radially expandedconfiguration, according to one embodiment.

FIG. 2 is a plan view of the distal end portion of the prostheticimplant delivery assembly with a stent of the prosthetic heart valve ofin a partially radially compressed configuration.

FIG. 3 is a perspective view of the prosthetic heart valve of theprosthetic implant delivery assembly of FIG. 1 .

FIG. 4 is a partial plan view of a delivery apparatus of the prostheticimplant delivery assembly of FIG. 1 .

FIG. 5 is a plan view of a distal portion of a first catheter of thedelivery apparatus.

FIGS. 6A and 6B are exploded views of a second catheter and a deliverycylinder of the delivery apparatus.

FIG. 6C is a plan view of the second catheter and the delivery cylinderof the delivery apparatus.

FIG. 7 is a plan view of the distal end portion of the deliveryapparatus.

FIG. 8 is a partial cross-sectional view of the delivery apparatus.

FIG. 9 is a plan view of a first manifold of the delivery apparatus.

FIG. 10 is a plan view of a second manifold of the delivery apparatus.

FIG. 11 is a perspective view of the prosthetic heart valve implanted ina native aortic annulus of a heart, shown in partial cross-section.

FIG. 12 is a perspective view of a distal end portion of a prostheticimplant delivery assembly with a stent in a radially expanded,functional configuration, according to another embodiment.

FIG. 13 is an elevation view of the distal end portion of the prostheticimplant delivery assembly with the stent in a radially compressedconfiguration.

FIG. 14 is an elevation view of the distal end portion of the prostheticimplant delivery assembly with the stent in an axially compressed,radially expanded configuration.

FIGS. 15-17 are various cross-sectional views of a delivery apparatusand plan views of a stent of a delivery assembly, according to anotherembodiment.

FIGS. 18-21C are various views another embodiment of a deliveryapparatus.

FIGS. 22-25 are various views of an example of another embodiment of adelivery apparatus.

FIGS. 26A-26C are various views of an example of another embodiment of adelivery apparatus.

FIGS. 27A-29 are various views of an example of another embodiment of adelivery apparatus.

FIGS. 30A-34 are various views of an example of another embodiment of adelivery apparatus.

FIG. 35 is a perspective view of another exemplary embodiment of adelivery assembly.

FIG. 36 is a perspective view of a prosthetic heart valve frame of thedelivery assembly of FIG. 35 .

FIGS. 37-38 are various views of a delivery apparatus of the deliveryassembly of FIG. 35 .

FIGS. 39-42 are various views of the delivery assembly of FIG. 35 .

FIG. 43 is a perspective view of an apex guide of the delivery assemblyof FIG. 35 .

FIG. 44 is a perspective view of another exemplary embodiment of an apexguide.

FIG. 45 is a perspective view of another exemplary embodiment of an apexguide.

FIG. 46 is a plan view of an exemplary embodiment of an attachmentmember and the apex guides of FIG. 43 .

FIG. 47 is a perspective view of the attachment member of FIG. 46 andthe delivery assembly of FIG. 35 .

FIG. 48 is a perspective view of a delivery assembly comprising anotherexemplary embodiment of a delivery apparatus and the prosthetic heartvalve frame of FIG. 36 .

FIG. 49 is a plan view of an apex guide of the delivery apparatus ofFIG. 48 .

FIGS. 50-52 are various views of the delivery assembly of FIG. 48 .

DETAILED DESCRIPTION

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedescribed methods, systems, and apparatus should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The disclosed methods, systems, and apparatus are notlimited to any specific aspect, feature, or combination thereof, nor dothe disclosed methods, systems, and apparatus require that any one ormore specific advantages be present or problems be solved.

Features, integers, characteristics, compounds, chemical moieties, orgroups described in conjunction with a particular aspect, embodiment orexample of the invention are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract, and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The invention is notrestricted to the details of any foregoing embodiments. The inventionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract, and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language set forthbelow. For example, operations described sequentially may in some casesbe rearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods, systems, and apparatus can be used in conjunctionwith other systems, methods, and apparatus.

As used herein, the terms “a,” “an,” and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “Band C,” or “A, B, and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

Embodiments of improved prosthetic implant delivery assemblies aredisclosed herein, as well as related methods and devices for suchassemblies. In several embodiments, the disclosed assemblies areconfigured for delivering replacement heart valves into a heart of apatient. The disclosed assemblies and methods can, for example, improvea physician's ability to control the expansion, repositioning, and/orretrieval of a prosthetic implant during an implantation procedure.

For example, in some embodiments, a delivery assembly (e.g., deliveryassembly 100) can used to deliver a self-expandable prosthetic heartvalve to a native annulus of a heart in a radially compressed state andcan be configured such that a physician can control the expansion of theprosthetic heart valve when the prosthetic valve is deployed from withina delivery sleeve or sheath. In some embodiments, for example, adelivery assembly can be used to recapture and/or reposition aprosthetic heart valve that has been deployed with a native annulus of aheart.

In some embodiments, a delivery assembly (e.g., the delivery assembly100) is adapted to deliver and implant a prosthetic heart valve in anative aortic annulus or valve of a heart (see, e.g., FIG. 9 ) using aretrograde approach, although in other embodiments it can be adapted todeliver and implant a prosthetic valve in the other native annuluses ofthe heart (e.g., the pulmonary, mitral, and tricuspid annuluses) and/orto be used with various other approaches (e.g., antegrade, transseptal,transventricular, transatrial, etc.).

A delivery assembly can also be adapted to deliver and implant aprosthetic valve in other tubular organs or passageways in the body.Further, in addition to prosthetic valves, a delivery assembly can beadapted to deliver and implant various other prosthetic devices such asstents and/or other prosthetic repair devices.

FIGS. 1-10 show an example of an embodiment of a delivery assembly 100.Referring first to FIG. 1 , the delivery assembly 100 can comprise aprosthetic heart valve 102 which is releasably coupled to a deliveryapparatus 104.

Referring now to FIG. 3 , the prosthetic valve 102 can comprise anannular stent or frame 106 and a valve structure 108 which is coupled tothe frame 106. The prosthetic valve 102 can have in inflow end portion110, and intermediate portion 112, and an outflow end portion 114.

The frame 106 can comprise a plurality of interconnected struts 116arranged in a lattice-type pattern and forming a first plurality ofapices 118 and a second plurality of apices 120 at the respective inflowand outflow ends 110, 114 of the prosthetic valve 102. At least some ofthe apices 118, 120 can have a respective opening or aperture 122 formedtherein (e.g., each apex 118, 120 has an aperture 122 in the illustratedembodiment). The apertures 122 can, for example, be used to releasablycouple the prosthetic valve 102 to the delivery apparatus 104, asfurther explained below (see, e.g., FIG. 1 ).

The frame 106 can be made of any of various suitableplastically-expandable materials (e.g., stainless steel, etc.) orself-expanding materials (e.g., nickel titanium alloy (“NiTi”), such asnitinol) as known in the art. When constructed of aplastically-expandable material, the frame 106 (and thus the prostheticvalve 102) can be crimped to a radially collapsed or compressedconfiguration or state on a delivery catheter and then expanded inside apatient by an inflatable balloon or equivalent expansion mechanism to anexpanded or functional state. When constructed of a self-expandablematerial, the frame 106 (and thus the prosthetic valve 102) can becrimped to a radially collapsed or compressed configuration andrestrained in the collapsed configuration by insertion into a sheath orequivalent mechanism of a delivery catheter. Once inside the body, theprosthetic valve can be advanced from the delivery sheath, which allowsthe prosthetic valve to radially expand to its functional state (e.g.,FIG. 3 ).

Further details regarding the collapsible transcatheter prosthetic heartvalves, including the manner in which the valve structure 108 can becoupled to the frame 106 of the prosthetic valve 102 can be found, forexample, in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394,and 8,652,202, which are incorporated herein by reference in theirentirety.

Referring now to FIG. 4 , the delivery apparatus 104 can generallycomprise a first catheter 124, a second catheter 126 extending coaxiallythrough the first catheter 124, a delivery cylinder 128 coupled todistal ends of the catheters 124, 126, and a guide-wire catheter 130extending coaxially through the catheters 124, 126 and the deliverycylinder 128. The proximal ends of the catheters 124, 126, 130 canextend to and/or be coupled to a handle 132.

As best shown in FIG. 5 , the first catheter 124 can comprise anelongate shaft comprising a proximal shaft portion 134 extendingdistally from the handle 132, an intermediate portion 136 extendingdistally from the distal end of the proximal shaft 134, and a distal endportion 138 extending distally from the distal end of the intermediateportion 136. The intermediate portion 136 can comprise a plurality of acircumferentially spaced rails 140 extending axially from the proximalshaft 134 to the distal end portion 138. The rails 140 can be configuredto engage a nut 142 (FIG. 6A) so as to prevent rotation of the nut 142but allow axial movement or translation of the nut 142 upon rotation ofthe second catheter 126, as further described below. The distal endportion 138 can, for example, comprise a slotted tube to enhance theflexibility of the distal end portion 138 of the first catheter 124. Thedistal end portion 138 can, for example, be formed by laser-cutting ametal tube (e.g. a stainless steel or nitinol tube).

As best shown in FIGS. 6A-6C, the second catheter 126 can comprise anelongate shaft 144 (which can be referred to as a torque shaft) and athreaded member or screw 146 connected to the distal end of the torqueshaft 144. The proximal end of the torque shaft 144 can be coupled tothe handle 132, for example, by a coupling member (not shown). Thethreaded member can have external threads configured to engagecorresponding internal threads of the nut 140. As such, the nut 142 canbe mounted to the threaded member 146, as best shown in FIG. 6B.

Referring still to FIGS. 6A-6C, the delivery cylinder 128 can comprise arelatively more flexible proximal portion 148 and a relatively lessflexible distal sheath portion 150 (which can be referred to as a sleeveor sheath). The proximal portion can comprise a slotted tube or cylinder(e.g., a metal tube) to enhance the flexibility of the proximal portion148 of the delivery cylinder 128. The sheath 150 can be configured toextend over and retain a prosthetic valve in a radially compressed stateduring delivery of the prosthetic valve to an implantation location.

As best shown in FIGS. 1-2 , the guide-wire catheter 130 can comprise anose cone 152 connected to a distal end of a nose cone shaft 154. Thenose cone shaft 154 can include a guide-wire lumen (not shown) forreceiving a guide-wire (not shown) and can extend proximally to thehandle 132 of the delivery apparatus 104.

Additional details regarding the regarding construction of the catheters124, 126, 130 and delivery cylinder 128 can be found, for example, inU.S. Pat. No. 9,155,619 and U.S. Patent Application Publication No.2014/0343670, which are incorporated herein by reference in theirentirety.

The delivery apparatus 104 can further comprise a first, distal manifoldor suture guide 156 and a second, proximal manifold or suture guide 158,as best shown in FIG. 1 . As shown in the illustrated embodiment, thefirst manifold 156 can, for example, be coupled to the nose cone shaft154 of the guide-wire catheter 130. The second manifold 158 can becoupled to the distal end of a suture retention member 160 which can becoupled to the distal end of the distal end portion 138 of the firstcatheter 124, as best shown in FIG. 5 .

Referring now to FIGS. 9-10 , the first manifold 156 can have aplurality of circumferentially spaced suture openings 162 (e.g., four inthe illustrated embodiment) disposed radially outward from a centrallydisposed lumen 164. The second manifold 158 can have a first, innerplurality of circumferentially spaced suture openings 166 (e.g., four inthe illustrated embodiment) disposed radially outward from a centrallydisposed lumen 168 and configured to radially and circumferentiallyalign with the openings 162 of the first manifold 156. The secondmanifold can, optionally, have a second, outer plurality ofcircumferentially spaced suture openings 170 (e.g., eight in theillustrated embodiment) disposed radially outward from the inneropenings 166.

Each plurality of openings 162, 166, 170 can, for example, comprise 2-20openings. For example, in some embodiments, each plurality can comprise4, 6, or 8 openings. In some embodiments, at least some of thepluralities of openings 162, 166, 170 can comprise the same number ofopenings. In other embodiments, at least some of the pluralities ofopenings 162, 166, 170 can comprise a different number of openings.

The first and the second manifolds 156, 158 can be used to releasablycouple the prosthetic valve 102 to the delivery apparatus with suturesor wires. For example, as shown in FIG. 1 , the inflow end 110 of theprosthetic valve 102 can be releasably coupled to the delivery apparatus104 by a first plurality of suture loops 172, and the outflow end 114 ofthe prosthetic valve 102 can be releasably coupled to the deliveryapparatus 104 by a second plurality of suture loops 174. The first andthe second manifolds 156, 158 can also be used to control and/ormanipulate the expansion and compression of the prosthetic valve 102when the prosthetic valve is exposed from the delivery sheath 150, asfurther described below.

Each suture 172 can form a loop which extends distally from the handle132 to the distal end of the delivery apparatus 104 and then proximallyback to the handle 132. For example, each suture 172 can extend distallyfrom the handle 132 and coaxially through the catheters 124, 126 and thesuture retention member 160. Each suture 172 can exit the sutureretention member through a respective radially extending port 176 (theport 176 extending radially from a lumen (not shown) of the sutureretention member 160) at the proximal end of the suture retention member160. Each suture 172 can then extend distally through a respective inneropening 166 of the second manifold 158, along the nose cone shaft 154through the prosthetic valve 102, and through a respective opening 162of the first manifold 156. Each suture loop 172 can then extend radiallyoutward and circumferentially through at least one (three in theillustrated embodiment) opening 122 of an apex 118 at the inflow end 110of the prosthetic valve 102. Each suture 172 can then extend radiallyinward and proximally through the respective opening 162 of the firstmanifold 156, along the nose cone shaft 154 through the prosthetic valve102, through the respective inner opening 166 of the second manifold158. Each suture 172 can then radially enter the suture retention member160 through the respective port 176 and can extend coaxially through thesuture retention member 160 and the first and the second catheters 124,126 back to the handle 132.

Similarly, each suture 174 can form a loop which extends distally fromthe handle 132 to the distal end of the delivery apparatus 104 and thenproximally back to the handle 132. For example, each suture 174 canextend distally from the handle and coaxially through the first and thesecond catheters 124, 126 and the suture retention member 160 and canradially exit the suture retention member 160 through a respective port176. Each suture 174 can then extend distally through a respective outeropening 170 of the second manifold 158. Each suture 174 can then extendradially outward and circumferentially through at least one (two in theillustrated embodiment) opening 122 of an apex 120 at the outflow end114 of the prosthetic valve 102. Each suture 174 can then extendradially inward and proximally through the respective outer opening 170of the second manifold 158. Each suture 174 can then radially enter thesuture retention member 160 through the respective port 176 and canextend coaxially through the suture retention member 160 and the firstand the second catheters 124, 126 back to the handle 132.

Although the sutures 172, 174 are releasably coupled to the prostheticvalve 102 via the openings 122 in the apices 118, 120, it should benoted that the sutures 172, 174 can be releasably coupled to therespective inflow and outflow ends 110, 114 in various other ways. Forexample, the sutures 172, 174 can be releasably coupled to theprosthetic valve by wrapping the sutures 172, 174 around a respectiveapex 118, 120 of the prosthetic valve 102.

As best shown in FIGS. 7-8 , when the delivery apparatus 104 isassembled, the torque shaft 144 of the second catheter 126 extendscoaxially through the proximal shaft portion 134 of the first catheter124, and the threaded member 146 of the second catheter 126 extendscoaxially through the rails 140 of the first catheter 124. The nut 142is mounted on the threaded member 146 and is connected to the proximalend portion of the delivery cylinder 128. The distal end portion 138 ofthe first catheter 124 extends coaxially through the delivery cylinder128.

In this manner, the delivery cylinder 128 cooperates with the threadedmember 146 and the nut 142 to allow for axial (i.e., proximal and/ordistal) movement of the delivery cylinder 128 relative to the distalshaft portion 138 and the suture-retention member 160. Rotational motionof the threaded member 146 (initiated by the user rotating the torqueshaft 144) can be converted into translational movement of the deliverycylinder 128 via the nut 142 positioned along external threads of thethreaded member 146 (FIG. 6B). The nut 142 can further comprise one ormore tabs 178 protruding radially outward, and the delivery cylinder 128can comprise one or more windows or openings 180 adjacent a proximal endof the cylinder 128 for engaging the tabs 178. In particular, upperportions of the tab(s) 178 can extend through the openings(s) 180 toproduce a secure fit (e.g., a snap fit) with the delivery cylinder 128.

As noted above, the first catheter 124 includes the intermediate section136 that includes a plurality of circumferentially spaced rails 140,which cooperate with the tab(s) 178 of the nut 142. As best shown inFIG. 8 , the threaded member 146 extends coaxially through the rails140, and the nut 142 is disposed on the threaded member 146 with eachtab 178 positioned in the space between two adjacent rails 140. Relativemovement between the delivery cylinder 128 and the first catheter 124occurs by rotating the torque shaft 144. Placement of the tab(s) 178between the rails 140 prevents the nut 142 from rotating along with thethreaded member 146. With rotation of the nut 142 restricted, rotationof the threaded member 146 produces translational or axial movement ofthe nut 142 along the threaded member 146. Axial movement of the nut 142along the threaded member 146 (in the distal or proximal direction)causes the delivery cylinder 128 to also move axially in the samedirection as the nut 142 (relative to the threaded member 146). Thus, asthe nut 142 moves axially along the threaded member 146, the deliverycylinder 128 (connected to the nut 142 at the openings 180 via the tabs178) is carried axially along-with the nut 142.

In the case of a threaded member 146 and a nut 142 with standard-type,right-handed threads, clockwise rotation of the threaded member 146 canresult in proximal movement of the nut 142 along the threaded member146. Conversely, counter-clockwise rotation of the standard threadedmember 146 can result in distal movement of the nut 142. In this manner,rotation of the threaded member 146 can cause proximal or distalmovement of the delivery cylinder 128 connected to the nut 142.Alternatively, the threads of the threaded member 146 can be reversedsuch that counter-clockwise rotation of the threaded member 146 causesproximal movement of the nut 142 and clockwise movement of the nut 142causes distal movement of the nut 142.

FIG. 4 shows the delivery cylinder 128 advanced forward to itsdistal-most position for delivery. In the delivery configuration, thesheath 150 of the delivery cylinder 128 extends over the prostheticvalve (not shown), which is retained in a radially compressed state andreleasably connected to the first and the second manifolds 156, 158 ofthe delivery apparatus 104 with the first and the second plurality ofsutures 172, 174. The distal end of the sheath 150 can abut the nosecone 152 when the delivery cylinder 128 is in the deliveryconfiguration.

FIG. 1 shows the delivery cylinder 128 retracted to a proximal positionfor deployment of the prosthetic valve 102. In the deploymentconfiguration, the sheath 150 is retracted proximally past the firstmanifold 156, the prosthetic valve 102, and the second manifold 158.When the frame 106 of the prosthetic valve 102 is formed from aself-expanding material, exposing the prosthetic valve 102 from withinthe sheath 150 of the delivery apparatus 104 allows the prosthetic valve102 to partially radially expand, as shown in FIG. 2 . In the partiallyradially expanded state, the apices 118, 120 at the inflow and theoutflow ends 110, 114 of the prosthetic valve can remain radiallycompressed or converged via tension of the sutures 172, 174, but theintermediate portion 112 of the prosthetic valve 102 can radiallyexpand. As a result, the prosthetic valve 102 comprises a generallyelliptical shape in the partially expanded state.

The prosthetic valve 102 can then be fully expanded from the partiallyradially expanded state to the functional state by reducing tension onthe sutures 172, 174, as shown in FIG. 1 . The prosthetic valve 102radially expands when exposed from within the sheath 150 and whentension is reduced on the sutures 172, 174 due to the outward biasingforce of the prosthetic valve's self-expanding frame 106.

The delivery apparatus 104 can be configured such that the tension ofthe sutures 172, 174 can be independently adjusted or manipulated. Forexample, the tension on the sutures 172, 174 can be reduced slowly orgradually, which in turn causes the prosthetic valve 102 to slowly orgradually expand to it functional state. This can advantageously preventthe prosthetic valve 102 from migrating or “jumping” relative to anative annulus of a heart during expansion of the prosthetic valveduring an implantation procedure.

The delivery apparatus 104 can also be configured such that the tensionof the sutures 172 can be adjusted independently from the tension of thesutures 174, or vice versa. In this manner, the inflow and the outflowends 110, 114 of the prosthetic valve can be radially expanded orcompressed individually.

This can be accomplished, for example, by releasably connecting thesutures to one or more reels disposed at or adjacent to the handle 132.The reels can be configured to wind the sutures 172, 174 onto the reels,which foreshortens the sutures 172, 174, thus increasing the tension onthe sutures 172, 174 and causing the inflow and outflow ends 110, 114 ofthe prosthetic valve to radially converge. The reels can be configuredto unwind the sutures 172, 174 from the reels, which elongates thesutures 172, 174, thus reducing the tension on the sutures 172, 174 andallowing the prosthetic valve to radially expand.

When the prosthetic valve 102 is in the fully radially expanded state(e.g., FIG. 1 ), the prosthetic valve 102 can be repositioned and/orretrieved by increasing the tension on the first and/or the secondplurality of sutures 172, 174 which causes the apices 118 and/or theapices 120 to radially converge to the partially radially expanded state(e.g., FIG. 2 ). In the partially radially expanded state, theprosthetic valve 102 can be repositioned relatively more easily thanwhen the prosthetic valve 102 is in the fully radially expanded statebecause the prosthetic valve 102 at least partially disengages thenative annulus, thereby allowing the prosthetic valve 102 to moverelatively more easily within the native annulus. The prosthetic valve102 can also be retrieved or retracted into the sheath 150 of thedelivery apparatus 104 relatively more easily in the partially radiallyexpanded state because the apices 118, 120 of the prosthetic valve 102more easily fit within the sheath 150 when the apices 118, 120 radiallyconverge. Thus, this state reduces the forces (e.g., axial and/orcompressive) which are required to pull the prosthetic valve 102 backinto sheath 150 or to push the sheath 150 back over the prosthetic valve102.

When the prosthetic valve 102 is desirably positioned with a nativeannulus, the prosthetic valve 102 can be fully radially expanded to itsfunctional state, thus securing or allowing the prosthetic valve 102 tobe secured within the native annulus. The prosthetic valve 102 can thenbe released from the delivery apparatus 104 by releasing the apices 118,120 from the sutures. This can be accomplished by retracting the sutures172, 174 from the openings 122 of the apices 118, 120, therebydisengaging the prosthetic valve 102 from the delivery apparatus. Thedelivery apparatus 104 can then be retracted proximally and removed fromthe patient's body, leaving the prosthetic valve 102 in the nativeannulus of the heart. For example, FIG. 11 shows the prosthetic valve102 implanted within a native aortic annulus 182 a heart 184.

FIGS. 12-14 show an example of another embodiment of a deliveryapparatus 200, which is similar to the delivery apparatus 104. Thedelivery apparatus 200 can, for example, be a component of a deliveryassembly comprising a prosthetic heart valve and the delivery apparatus200. For example, FIGS. 12-14 show a delivery assembly comprising theprosthetic heart valve 102 and the delivery apparatus 200. For purposesof illustration, FIGS. 12-14 show only the frame 106 of the prostheticvalve 102 but omit other components of the prosthetic valve 102, such asthe valve structure 108. The frame 106 is shown in FIG. 12 as beingsubstantially cylindrical, however, it should be noted that the frame106 can have a curved profile as shown in FIG. 3 .

Although not shown, the delivery apparatus 200 can comprise a firstcatheter, a second catheter, a delivery cylinder, and a handle (e.g.,similar to the first catheter 124, the second catheter 126, the deliverycylinder 128, and handle 132 of the delivery apparatus 104). The firstand the second catheters and the delivery cylinder can be configured tocooperate in a manner similar to those of the delivery apparatus 104.For example, the delivery apparatus 200 can be configured such thatrotating a rotatable torque shaft that extends coaxially through thefirst catheter causes a sheath that operatively coupled to a distal endof the torque shaft to retract or advance the sheath relative to aprosthetic valve, as described above with respect to delivery apparatus104.

Referring to FIG. 12 , the delivery apparatus 200 can further comprise aguide-wire catheter 202, a first suture manifold 204, a second suturemanifold 206 connected to the distal end of a suture retention member208, and first and second pluralities of sutures 210, 212. Each of thesecomponents, as well as their interaction together, is further describedbelow.

The guide-wire catheter 202 can comprise a nose cone 214 connected tothe distal end of a nose cone shaft 216, and an axially extendingguide-wire lumen (not shown). The nose cone shaft 216 can extenddistally from a handle and coaxially through the first and the secondcatheters, the delivery cylinder, the suture retention member 208, andthe second manifold 206, and the first manifold 204. The nose cone shaft216 can be configured to be independently axially (i.e., distally orproximally) moveable relative to the first and the second catheters, thedelivery cylinder, the suture retention member 208, and the secondmanifold 206. This can be accomplished, for example, by forming acentral lumen through the delivery apparatus 200 (or by forming aplurality of lumens which collectively form the central lumen) throughwhich the nose cone shaft 216 axially extends.

The first suture manifold 204 can have a plurality of circumferentiallyspaced suture openings 218 (e.g., eight in the illustrated embodiment)disposed radially outward from a centrally disposed lumen (not shown,but see, e.g., lumen 164 (FIG. 9 )). The first manifold 204 can bemounted on the distal end of the nose cone shaft 216, proximal to thenose cone 214.

The second manifold 206 can have a plurality of circumferentially spacedsuture openings 220 (e.g., eight in the illustrated embodiment) disposedradially outward from a centrally disposed lumen (not shown, but see,e.g., lumen 168 (FIG. 10 )) and configured to radially andcircumferentially align with the openings 218 of the first manifold 204.Although not shown, the second manifold 206 can, optionally, have asecond, outer plurality of circumferentially spaced suture openings(see, e.g., the openings 170 (FIG. 10 )) disposed radially outward fromthe openings 220.

Each plurality of openings (e.g., 218, 220) can, for example, comprise2-20 openings. For example, in some embodiments, each plurality cancomprise 4, 6, or 8 openings. In some embodiments, at least some of thepluralities of openings can comprise the same number of openings. Inother embodiments, at least some of the pluralities of openings cancomprise a different number of openings.

As noted above, the second manifold 206 can be connected to the sutureretention member 208. In some embodiments, the second manifold 206 andthe suture retention member 208 can be connected by forming the secondmanifold 206 and the suture retention member 208 from separate pieces ofmaterial and connecting the pieces by a suitable means, such as welding,fasteners, and/or an adhesive. In other embodiments, the second manifold206 and the suture retention member 208 can be connected by forming thesecond manifold 206 and the suture retention member 208 from a single,unitary piece of material.

The suture retention member 208 can mounted on the distal end of thefirst catheter (similar to the manner in which the suture retentionmember 160 is mounted on the distal end of the first catheter 124 (see,e.g., FIG. 5 )). The suture retention member 208 can have a plurality ofports 222 each of which extend radially from an axially extending lumen(not show) which extends through the suture retention member 208, asbest shown in FIG. 13 .

Referring again to FIG. 12 , the first and the second pluralities ofsutures 210, 212 can be used to releasably couple the prosthetic valve102 to the delivery apparatus 200. For example, the first plurality ofsutures 210 can be used to releasably couple the inflow end 110 of theprosthetic valve 102 to the delivery apparatus 200, and the secondplurality of sutures 212 can be used to releasably couple the outflowend 114 of the prosthetic valve 102 to the delivery apparatus 200.

The first and the second pluralities of sutures 210, 212 can also beused to control the expansion and/or compression of the inflow and theoutflow ends 110, 114 of the prosthetic valve 102, as further describedbelow. The first and the second pluralities of sutures 210, 212 can beconfigured to be independently adjustable and/or moveable relative toeach other.

Each suture 210 can form a loop which extends distally from the handleto the distal end of the delivery apparatus 200 and then proximally backto the handle. For example, each suture 210 can extend distally from thehandle and coaxially through the first and the second catheters and thesuture retention member 208 and can radially exit the suture retentionmember 208 through a respective port 222. Each suture 210 can thenextend distally through a respective opening 220 of the second manifold206, along the nose cone shaft 216 through the prosthetic valve 102, andthrough a respective opening 218 of the first manifold 204. Each suture210 can then extend radially outward and circumferentially through atleast one (e.g., three in the illustrated embodiment) opening 122 of anapex 118 at the inflow end 110 of the prosthetic valve 102. Each suture210 can then extend radially inward and proximally through therespective opening 218 of the first manifold 204, along the nose coneshaft 216 through the prosthetic valve 102, through the respectiveopening 220 of the second manifold 206. Each suture 210 can thenradially enter the suture retention member 208 through the respectiveport 222 and can extend coaxially through the suture retention member208 and the first and the second catheters back to the handle.

Similarly, each suture 212 can form a loop which extends distally fromthe handle to the distal end of the delivery apparatus 200 and thenproximally back to the handle. For example, each suture 212 can extenddistally from the handle and coaxially through the first and the secondcatheters and the suture retention member 208 and can radially exit thesuture retention member 208 through a respective port 222. Each suture212 can then extend distally through a respective opening 220 of thesecond manifold 206. Each suture 210 can then extend radially outwardand circumferentially through at least one (two in the illustratedembodiment) opening 122 of an apex 120 at the outflow end 114 of theprosthetic valve 102. Each suture 210 can then extend radially inwardand proximally through the respective opening 220 of the second manifold206. Each suture 210 can then radially enter the suture retention member208 through the respective port 222 and can extend coaxially through thesuture retention member 208 and the first and the second catheters backto the handle.

In this manner, the sutures 210, 212 can be used to control the radialexpansion or compression of the inflow and the outflow ends 110, 114 ofthe prosthetic valve 102. For example, when the prosthetic valve 102 isreleasably coupled to the delivery apparatus 200 and exposed from withinthe sheath of the delivery apparatus 200, reducing tension on sutures210, 212 allows the inflow and the outflow ends 110, 114 of theprosthetic valve 102 to radially diverge or expand from the radiallyconverged or compressed state (e.g., FIG. 14 ) to the radially expanded,functional state (e.g., FIG. 12 ).

In addition, configuring the delivery apparatus 200 so that theguide-wire catheter 202 is axially moveable relative to other componentsof the delivery apparatus 200, such as the first and the secondcatheters, provides additional control and manipulation of theprosthetic valve 102. For example, in addition to being able to radiallyconverge and/or expand the inflow and the outflow ends 110, 114 of theprosthetic valve 102, the intermediate portion 112 of the prostheticvalve 102 can be radially compressed and/or expanded by moving the nosecone shaft 204 axially (i.e., distally and/or proximally) relative tothe first and the second catheters and/or by moving the first and secondcatheters relative to the nose cone shaft 204. Relative axial movementof the nose cone shaft 216 causes the first and the second manifolds204, 206 to axially diverge or converge, thereby causing theintermediate portion 112 of the prosthetic valve 102 to axially elongateand radially compress or to axially foreshorten and radially expand.

For example, FIG. 13 shows the prosthetic valve 102 in the axiallyelongate, radially compressed state. This configuration can be achievedby increasing the tension on the sutures 210, 212, such that the inflowand the outflow ends 110, 114 of the prosthetic valve 102 radiallyconverge, and then by advancing the nose cone shaft 216 distally suchthe first manifold 204 moves farther away from the second manifold 206which applies axial tension on the inflow and the outflow ends 110, 114of the prosthetic valve 102 and causes the intermediate portion 112 ofthe prosthetic valve 102 to axially elongate and radially compress. Forexample, in the axially elongate, radially compressed state (FIG. 13 )the prosthetic valve 102 can have a length L₁ which is greater than alength L₂ of the prosthetic valve 102 in the relaxed, functional state(FIG. 12 ), and the prosthetic valve 102 can have a diameter D₁ which isless than a diameter D₂ of the prosthetic valve 102 in the relaxed,functional state. Thus, moving the manifolds 204, 206 away from eachother causes the prosthetic valve 102 to axially elongate and radiallycompress while moving the manifolds 204, 206 toward each other allowsthe prosthetic valve 102 to axially foreshorten and radially expand.

The prosthetic valve 102 can be repositioned within a native annulus ofa heart and/or retrieved into the sheath of the delivery apparatus 200relatively more easily in the axially elongate, radially compressedstate (FIG. 11 ) than in the radially expanded, functional state (FIG.12 ).

When the prosthetic valve 102 is in the axially elongate, radiallycompressed state the prosthetic valve 102 can be expanded to thefunctional state by reducing tension on the prosthetic valve 102. Thiscan be accomplished by reducing tension of the sutures 210, 212, which,due to the self-expanding biasing force of the prosthetic valve 102attempting to reach its resting state, causes the first and the secondmanifolds 204, 206 to move closer together, thereby allowing the apices118, 120 and the intermediate portion 112 of the prosthetic valve 102 toradially expand. Alternatively, the manifolds 204, 206 can be movedtoward each other (e.g., by moving the nose cone shaft 216 proximallyrelative to the first catheter) while maintaining tension on the sutures210, 212, allowing the intermediate portion 112 of the prosthetic valve102 to radially expand while retaining the ends of the prosthetic valve102 in the radially compressed state such that the prosthetic valve 102attains the partially expanded state of FIG. 2 .

In the partially expanded state of FIG. 2 (the ends of the prostheticvalve 102 are radially compressed, but the prosthetic valve 102 is notaxially elongated), the prosthetic valve 102 has an outer diameter D₄and a length L₄. With the prosthetic valve 102 in the partially expandedstate, the delivery apparatus 200 can also be used to mechanicallyradially expand the prosthetic valve 102 beyond the partially expandedstate, as shown in FIG. 14 . This can be accomplished by moving themanifolds 204, 206 toward each other (e.g., moving the first manifold204 proximally toward the second manifold 206 and/or moving the secondmanifold 206 distally toward the first manifold 204). This causes thefirst and the second manifolds 204, 206 to axially compress theprosthetic valve 102 such that an axial length L₃ of the prostheticvalve 102 is less than the axial length L₁ and L₄, thereby causing theintermediate portion 112 of the prosthetic valve 102 to radially expandsuch that a diameter D₃ of the prosthetic valve 102 is greater than thediameter D₄. The prosthetic valve 102 can be further axially compressedto further radially expand to a diameter D₃ which is greater than thediameter D₂.

In some embodiments, the delivery apparatus 200 can be used tomechanically radially expand the prosthetic valve 102 without firstconverging the ends of the prosthetic valve 102. For example, with theprosthetic valve 102 in the functional state (e.g., FIG. 12 ), themanifolds 204, 206 can be moved toward each other (e.g., moving thefirst manifold 204 proximally toward the second manifold 206 and/ormoving the second manifold 206 distally toward the first manifold 204).This causes the first and the second manifolds 204, 206 to axiallycompress the prosthetic valve 102 such that an axial length of theprosthetic valve 102 is less than the axial length L₂, thereby causingthe intermediate portion 112 of the prosthetic valve 102 to radiallyexpand such that a diameter of the prosthetic valve 102 is greater thanthe diameter D₂.

Allowing a physician to force the prosthetic valve to radially expandbeyond itself self-expanded state by using the delivery apparatus 200provides several significant advantages. For example, oftentimes anative annulus applies a sufficient radial force to the prosthetic valvesuch the prosthetic valve will not fully radially expand to a desireddiameter under its own self-expanding force when deployed within thenative valve annulus. This can result in decreased efficiency for theprosthetic valve and/or undesired paravalvular leakage. These problemscan be particularly prevalent in native annuluses with stenosis and/orcalcification. Such cases typically require a balloon post-dilationprocedure to further expand the prosthetic valve to the desired diameterafter the initial implantation. Alternatively, the delivery apparatus200 can be used apply a sufficient axially compressive force to theprosthetic valve 102, which causes the prosthetic valve to radiallyexpand (similar to a balloon) and dilate the annulus such that when thecompressive force is removed from the prosthetic valve 102, theprosthetic valve has a resting diameter which is closer to the desiredfinal functional diameter. Thus, the delivery apparatus 200 canadvantageously improve the efficiency and paravalvular leakage. Thedelivery apparatus 200 can also advantageously reduce procedural timesby reducing or eliminating the need for a balloon post-dilationprocedure.

For example, in one particular embodiment, a prosthetic valve having anominal expanded diameter of about 29 mm might expand under its ownresiliency to a diameter of about 26.2 mm when deployed in a calcifiednative annulus. The delivery apparatus 200 can be used to furtherradially expand the prosthetic valve and further dilate the annulus byapplying an axially compressive force to the prosthetic valve (see,e.g., FIG. 14 ) such that the prosthetic valve has a diameter of about30 mm while under axial compression from the delivery apparatus 200.When the axially compressive force of the delivery apparatus 200 isremoved, the prosthetic valve can relax to a diameter of 28 mm. Thus,the delivery apparatus 200 can advantageously increase the restingdiameter of the prosthetic valve by 1.8 mm without requiring a balloonpost-dilation procedure.

FIGS. 15-17 show an example of another embodiment of a deliveryapparatus 300. The delivery apparatus 300 can, for example, be acomponent of a delivery assembly comprising a prosthetic heart valve(e.g., the prosthetic valve 102) and the delivery apparatus 300. Forpurposes of illustration, FIGS. 15-17 show only the frame 106 of theprosthetic valve 102 but omit other components of the prosthetic valve102, such as the valve structure 106.

Referring now to FIG. 15 , the delivery apparatus 300 can comprise afirst catheter 302, a second catheter 304 extending coaxially throughthe first catheter 302, a delivery cylinder 306 coupled to distal endsof the catheters 302, 304, and a guide-wire catheter 308 extendingcoaxially through the catheters 302, 304 and the delivery cylinder 306.The proximal ends of the catheters 302, 304, 308 can extend to and/or becoupled to a handle (not shown, but see, e.g., the handle 132). Thecatheters 302, 304, 308 can be independently moveable relative to eachother. The delivery cylinder 306 can be an extension of a separate shaftthat extends coaxially over the first catheter from the handle.

The delivery apparatus 300 can also comprise a suture retention member310 secured or coupled to a distal end of an elongate shaft portion 312of the first catheter 302, and a suture tensioning member 314 which iscoupled to a shaft 316. The suture tensioning member 314 can be disposedproximally relative to the suture retention member 310. The shaft 316can extend axially proximally from the suture tensioning member 314 tothe handle. In some embodiments, the shaft 316 can be a shaft portion ofthe second catheter 304, or alternatively, the shaft 316 can be a pullwire extending from the handle to the suture tensioning member 314.

The suture retention member 310 can comprise a manifold portion 318 atthe distal end and a proximal end portion 320 disposed proximallyrelative to the manifold 318. The suture member 310 can have a pluralityof openings (not shown) which axially extend through the manifold 318and the proximal end portion 320. The openings can be circumferentiallyspaced and can be disposed radially outward from a centrally disposedlumen 322 which extends axially through the suture retention member 310and allows a nose cone shaft 326 of the guide-wire catheter 308 toaxially extend through the suture retention member 310.

In some embodiments, the manifold 318 of the suture retention member 310can be a second manifold (similar to the second manifold 158) releasablycoupled to the proximal end of a prosthetic valve, and the deliveryapparatus 300 can comprise a first manifold (similar to the firstmanifold 156) mounted on the distal end of the nose cone shaft 326 andreleasably coupled to the distal end of the prosthetic valve in themanner shown in FIG. 1 .

The suture tensioning member 314 can comprise a plurality of axiallyextending openings (not shown). The openings can be circumferentiallyspaced and can be disposed radially outward from a centrally disposedlumen 324 which extends axially through the suture retention member 310and allows the nose cone shaft 326 of the guide-wire catheter 308 toaxially extend through the suture tensioning member 314.

The respective openings of the suture retention member 310 and thesuture tensioning member 314 can be used to releasably couple theprosthetic valve 102 to the delivery apparatus 300 via a plurality ofsutures 328. For example, each suture 328 can form a loop which extendsaxially distally from a proximal end of the suture tensioning member314, through a respective opening of the suture tensioning member 314,through a respective opening of the suture retention member 310, and tothe outflow end 114 of the prosthetic valve 102. The loop can thenextend radially through a respective aperture 122 of the prostheticvalve 102. The loop can then extend proximally from the outflow end 114of the prosthetic valve 102, through the respective opening of thesuture retention member 310, through a respective opening of the suturetensioning member 314, and to the proximal end of the suture tensioningmember 314.

As such, the suture retention member 310 and the suture tensioningmember 314 can be used to control the tension of the sutures 328, andthus, to control the radial expansion of prosthetic valve 102 when theprosthetic valve 102 is exposed from within the delivery cylinder 306.For example, as shown in FIG. 15 , moving the suture tensioning member314 distally relative to the suture retention member 310 lengthens theportions of the sutures 328 that are disposed between the sutureretention member 310 and the prosthetic valve 102, which decreasestension on the sutures 328 and allows the apices 120 of the outflow end114 of the prosthetic valve 102 to radially expand. This can beaccomplished, for example, by moving the shaft 316 distally or slowlyreleasing a restraining force on the shaft 316 which allows theself-expanding force of the prosthetic valve to pull the suturetensioning member 314 distally toward the suture retention member 310.

As shown, for example, in FIG. 16 , moving the suture tensioning member314 proximally relative to the suture retention member 310 foreshortensthe portions of the sutures 328 that are disposed between the sutureretention member 310 and the prosthetic valve 102, which increasestension on the sutures 328 and causes the apices 120 of the outflow end114 of the prosthetic valve 102 to radially converge. This can beaccomplished, for example, by pulling on the shaft 316 which moves thesuture tensioning member 314 proximally, away from the suture retentionmember 310.

Converging the apices 120 of the prosthetic valve 102 can, for example,allow the prosthetic valve to be relatively more easily moveable withina native annulus of a patient and/or more easily retrievable into thedelivery apparatus 300. For example, as shown in FIG. 17 , the deliverycylinder 306 can be advanced distally over the prosthetic valve 102 orthe prosthetic valve 102 can be retracted proximally into the deliverycylinder 306.

The sutures 328 can be configured such that the loops can be retractedfrom the apertures 122 of the prosthetic valve 102 to release theprosthetic valve 102 from the delivery apparatus 300. This can beaccomplished, for example, by releasably coupling the sutures 328 to thesuture tensioning member 314 by a release wire (not shown). Additionaldetails regarding releasably coupling a prosthetic valve to a deliveryapparatus, including by a release wire can be found, for example, inU.S. Patent Application Publication No. 2014/0343670.

FIGS. 18-21C show an example of another embodiment of a deliveryapparatus 400, which is similar to the delivery apparatus 300. Thedelivery apparatus 300 can, for example, be a component of a deliveryassembly comprising a prosthetic heart valve and the delivery apparatus400.

Referring to FIGS. 18-19 , the delivery apparatus 400 can comprise afirst catheter 402, a second catheter 404 extending coaxially throughthe first catheter 402, a delivery cylinder 406 coupled to distal endsof the catheters 402, 404, and a guide-wire catheter 436 (which can becalled a nose cone catheter) extending coaxially through the catheters402, 404 and the delivery cylinder 406. The proximal ends of thecatheters 402, 404, 436 can extend to and/or be coupled to a handle (notshown, but see, e.g., the handle 132). The catheters 402, 404, 436 canbe independently moveable relative to each other.

The delivery apparatus 400 can further comprise a suture retentionmember 430 coupled to the distal end of the first catheter 402 and asuture tensioning member 432 disposed proximal to the suture retentionmember 430 and coupled to the second catheter 204. In some embodiments,a distal suture manifold or suture guide 438 can be mounted on thedistal end of the nose-cone catheter 436 for coupling the distal end ofa prosthetic valve to the delivery apparatus as shown in FIG. 18 .

Referring to FIG. 20 , the first catheter 402 (similar to the firstcatheter 124) can comprise an elongate proximal shaft portion 408extending distally from the handle, an intermediate portion 410extending distally from the distal end of the proximal shaft 408, and adistal end portion 412 extending distally from the distal end of theintermediate portion 410. The intermediate portion 410 can comprise aplurality of a circumferentially spaced rails 414 extending axially fromthe proximal shaft 408 to the distal end portion 412. The rails 414 canbe configured to engage a proximal nut 416 and a distal nut 418 (FIG.21A) so as to prevent rotation of the nuts 416, 418 but allow axialmovement or translation of the nuts upon rotation of the second catheter404, as further described below.

As best shown in FIGS. 21A-21C, the second catheter 404 can comprise anelongate proximal shaft 420 (which can be referred to as a torqueshaft), a proximal threaded member or screw 422 connected to a distalend of the torque shaft 420, and a distal threaded member or screw 424connected to a distal end of the proximal threaded member 422. In someembodiments, the threaded members 422, 424 can be connected to eachother, for example, by forming the threaded members 422, 424 from asingle, unitary piece of material. In other embodiments, the threadedmembers 422, 424 can be connected to each other, for example, by formingthe threaded members 422, 424 from separate pieces of material which areconnected by welding, an adhesive, etc. The proximal end of the torqueshaft 420 can be coupled to the handle, for example, by a couplingmember (not shown).

The proximal threaded member 422 can have external threads configured toengage corresponding internal threads of the proximal nut 416. As such,the proximal nut 416 can be mounted to the proximal threaded member 422,as best shown in FIG. 21B. As also best shown in FIG. 21B, the nut 416can further comprise one or more tabs 426 protruding radially outward,and the delivery cylinder 406 can comprise one or more windows oropenings 428 adjacent a proximal end of the delivery cylinder 406 forengaging the tabs 426. In particular, upper portions of the tab(s) 426can extend through the openings(s) 428 to produce a secure fit (e.g., asnap fit) with the delivery cylinder 406.

The distal threaded member 424 can have external threads configured toengage corresponding internal threads of the distal nut 418. As such,the distal nut 418 can be mounted to the distal threaded member 424, asbest shown in FIG. 21B. As best shown in FIG. 21B, the nut 418 cancomprise one or more tabs 427 protruding radially outward, which areconfigured to engage the rails 414 of the first catheter 402.

Referring again to FIG. 19 , when the delivery apparatus 400 isassembled, the torque shaft 420 of the second catheter 404 extendscoaxially through the proximal shaft 408 of the first catheter 404, andthe threaded members 422, 422 of the second catheter 404 extendcoaxially through the rails 414 of the first catheter 402. The proximalnut 416 is mounted on the proximal threaded member 422 and is connectedto the proximal end portion of the delivery cylinder 406. The distal nut418 is mounted on the distal threaded member 424 and is coupled to thesuture tensioning member 432 (e.g., via a shaft 434). The distal endportion 412 of the first catheter 404 extends coaxially through thedelivery cylinder 406. In some embodiments, the shaft 434 can be anextension of the nut 418 or the second catheter 404.

As noted above, the first catheter 402 includes the intermediate section410 that includes a plurality of circumferentially spaced rails 414,which cooperate with the tab(s) 426, 427 of the nuts 416, 418. As bestshown in FIG. 19 , the threaded members 422, 424 extend coaxiallythrough the rails 414, and the nuts 416, 418 are disposed on respectivethreaded members 422, 424 with each tab 426 positioned in the spacebetween two adjacent rails 414.

As such, relative movement between the delivery cylinder 406 and thefirst catheter 406 can be effectuated by rotating the torque shaft 420.Placement of the tab(s) 426 between the rails 414 prevents the proximalnut 416 from rotating along with the proximal threaded member 422. Withrotation of the proximal nut 416 restricted, rotation of the proximalthreaded member 422 produces translational or axial movement of theproximal nut 416 along the proximal threaded member 422. Axial movementof the proximal nut 416 along the proximal threaded member 422 (in thedistal or proximal direction) causes the delivery cylinder 406 to alsomove axially in the same direction as the proximal nut 416 (relative tothe proximal threaded member 422). Thus, as the proximal nut 416 movesaxially along the proximal threaded member 422, the delivery cylinder406 (which is connected to the proximal nut 416 at the openings 428 viathe tabs 426) is carried axially along-with the proximal nut 416.

Similarly, relative movement between the suture retention member 430 andthe suture tensioning member 432 can be effectuated by rotating thetorque shaft 420. Placement of the tab(s) 427 between the rails 414prevents the distal nut 418 from rotating along with the distal threadedmember 424. With rotation of the distal nut 418 restricted, rotation ofthe distal threaded member 424 produces translational or axial movementof the distal nut 418 along the distal threaded member 424. Axialmovement of the distal nut 418 along the distal threaded member 424 (inthe distal or proximal direction) causes the shaft 434 and, thus, thesuture tensioning member 432 to also move axially in the same directionas the distal nut 418 (distal threaded member 424). Thus, as the distalnut 418 moves axially along the distal threaded member 424, the suturetensioning member 432 is carried axially along-with the distal nut 418,thereby moving the suture tensioning member 432 relative to the sutureretention member 430.

In some embodiments, the internal threads of the proximal nut 416 andthe corresponding external threads of the proximal threaded member 422can be configured with a first thread-type (e.g., left-handed), and theinternal threads of the distal nut 418 and the corresponding externalthreads of the distal threaded member 424 can be configured with second,opposite thread-type (e.g., right-handed) (similar to a turnbuckle). Inthis manner, rotating the torque shaft in a first direction (e.g.,clockwise) causes the delivery cylinder 406 to move axially distallyrelative to the suture retention member 430 and the suture tensioningmember 432 to move axially proximally relative to the suture retentionmember 430. Conversely, rotating the torque shaft in a second, oppositedirection (e.g., counterclockwise) causes the delivery cylinder 406 tomove axially proximally relative to the suture retention member 430 andthe suture tensioning member 432 to move axially distally relative tothe suture retention member 430.

In some embodiments, the internal threads of the proximal nut 416 andthe corresponding external threads of the proximal threaded member 422can be configured with a first thread-pitch (e.g., 0.635 mm), and theinternal threads of the distal nut 418 and the corresponding externalthreads of the distal threaded member 424 can be configured with second,different thread-pitch (e.g., 0.45 mm). As such, when the torque shaft420 rotates at rotational rate or speed (e.g., rpm), the proximal nut416 and the distal nut 418 can move axially along the respectivethreaded members 422, 424 at different axial rates or speeds (e.g.,mm/s) relative to the torque shaft 420. Thus, the delivery cylinder 406(which can be coupled to the proximal nut 416) can move axially morequickly relative to the suture retention member 430 and the prostheticvalve 102 than the suture tensioning member 432 (which can be coupled tothe distal nut 418).

Although not shown, a prosthetic valve can be releasably coupled to thedelivery apparatus 400 with sutures 440 (FIG. 18 ), for example, in amanner similar to which the prosthetic valve 102 is releasably coupledto the delivery apparatus 300 with sutures 328 (see, e.g., FIG. 15 ).

As such, after the prosthetic valve has been deployed from the deliverycylinder 406 of the delivery apparatus 400, the delivery apparatus 400can be used to simultaneously radially converge the apices of theprosthetic valve and to advance the delivery cylinder 406 over theprosthetic valve by rotating the torque shaft in a first direction. Theapices of the prosthetic valve radially converge as the suturetensioning member 432 moves proximally relative to the suture retentionmember 430 due to the increased tension on the sutures (see, e.g., FIG.17 ).

The delivery apparatus 400 also can be used to simultaneously expose theprosthetic valve from the delivery cylinder 406 and to radially expandthe apices of the prosthetic valve by rotating the torque shaft in asecond direction. The prosthetic valve becomes exposed from the deliverycylinder 406 as the delivery cylinder 406 moves proximally relative tothe prosthetic valve, and the apices of the prosthetic valve radiallyexpand as the suture tensioning member 432 moves distally relative tothe suture retention member 430 due to the decreased tension on thesutures and the self-expanding force of the prosthetic valve (see, e.g.,FIG. 15 ).

FIGS. 22-25 show an example of a delivery apparatus 500, according toone embodiment. As shown in FIG. 22 , the delivery apparatus 500 can,for example, be a component of a delivery assembly comprising aprosthetic valve (e.g., the prosthetic valve 102) and the deliveryapparatus 500.

Referring still to FIG. 22 , the deliver apparatus 500 can comprise afirst, proximal portion 502 and a second, distal portion 504. The firstand second portions 502, 504 can be separately formed, and the secondportion 504 can be coupled to the distal end of the first portion 502,as further explained below.

The first portion 502 of the delivery apparatus 500 can comprise a firstcatheter 506 (which can be referred to as an implant delivery catheter)and a second catheter 508 (which can be referred to as a guide-wirecatheter) extending coaxially through the first catheter 508. Theproximal ends of the catheters 506, 508 can extend to and/or be coupledto a handle 510. The catheters 506, 508 can be independently moveable(e.g., axially and/or rotatably) relative to each other.

The first catheter 506 can comprise an elongate proximal shaft portion512 extending distally from the handle 510, an intermediate portion (notshown) extending distally from the distal end of the proximal shaft 512,and a distal end portion 514 extending distally from the distal end ofthe intermediate portion. The distal end portion 514 can, for example,comprise a slotted tube to enhance the flexibility of the distal endportion 514 of the first catheter 506. A separate sheath (not shown) canextend over the shaft 512, and the distal end portion 514 for retaininga prosthetic valve 102 in a compressed state for delivery into apatient.

Referring to FIG. 24A, the second catheter 508 can have an elongateguide-wire shaft 516 extending distally from the handle 510 (FIG. 22 )and a pusher element 518 which is connected to the distal end of theguide-wire shaft 516. The pusher element 518 can have centrally radiallydisposed lumen 520 and a push pin 522 disposed radially outward from thelumen 520 and extending distally from the distal surface of the pusherelement 518. The lumen 520 can have a radially tapered or funnel portion524, which can help to direct a guide-wire (not shown) into a lumen 526of the guide-wire shaft 516 when the guide-wire is initially insertedinto the delivery apparatus 500.

The second portion 504 of the delivery apparatus 500 can comprise asuture retention member 528 and a nose-cone shaft 530 connected to andextending distally from the suture retention member 528. The sutureretention member 528 can have a proximal portion 532, a distal portion534, a radially recessed intermediate portion 536 disposed between theproximal and distal portions 532, 534. The second portion 504 can alsohave a radially centrally disposed, first lumen 538 (FIG. 24C) extendingcoaxially through the suture retention member 528, the nose-cone shaft530, and a nose cone 558 (which is connected to the distal end of thenose-cone shaft 530).

The proximal and distal portions 532, 534 of the suture retention member528 can each have a respective second lumen 540 which extends axiallythrough a respective proximal or distal portion 532, 534 and is disposedradially outward from the intermediate portion 536 (see also, FIG. 23C).A release pin 542 can be disposed in the second lumens 540 and can beaxially moveable within the second lumens 540 between a first, proximalposition (e.g., FIG. 24A) and a second, distal position (e.g., FIG.24C). As best shown in FIG. 24A, in the first position, a proximal endportion 544 of the release pin 542 is disposed within the proximalportion 532 of the suture retention member 528 and a distal end portion546 of the release pin 542 is disposed within the distal portion 534 ofthe suture retention member 528. As best shown in FIG. 24C, in thesecond position, the proximal end 544 of the release pin 542 is disposedwithin the distal portion 534 of the suture retention member 528 and thedistal end 546 of the release pin 542 extends distally from the distalportion 534 of the suture retention member 528.

As best shown in FIG. 24A, the proximal end portion 544 of the releasepin 542 can have a larger diameter than an adjacent portion of therelease pin 542. The distal end portion 546 of the release pin 542 canhave a larger diameter than an adjacent portion of the release pin 542and/or can have an annular ridge 548 which extends radially outward fromthe distal end portion 546 of the release pin 542.

As best shown in FIG. 24B, the second lumen 540 of the distal portion534 can have an annular lip or shoulder portion 550, which extendsradially inward. The lip 550 can be configured to have a diameter thatis less than the diameters of the proximal end portion 544 and the ridge548 of the release pin 542 but approximately equal or slightly greaterthan the diameter of the portions of the release pin 542 that areadjacent to the distal end 548 and the ridge 548 of the release pin 542.

In this manner, the lip 550 can prevent the proximal end portion 544 ofthe release pin 542 from moving axially distally past the lip 550 as therelease pin 542 moves from the first position (e.g., FIG. 24A) to thesecond position (e.g., FIG. 24C). Similarly, the lip 550 can alsoprevent the ridge 548 of the release pin 542 from moving axiallyproximally past the lip 550 as the release pin 542 moves from the secondposition to the first position.

A prosthetic valve can be releasably coupled to the second portion 504of the delivery apparatus 500 by sutures. For example, FIG. 22 shows theprosthetic valve 102 coupled to the second portion 504 of the deliveryapparatus 500 by a suture loop 552. As best shown in FIG. 25 , thesuture loop 552 can extend radially through an aperture 122 of an apex120 (or around the apex) of the prosthetic valve 102 andcircumferentially around the release pin 522 of the suture retentionmember 528. The suture loop 552 can be wrapped around the release pin542 by positioning the release pin 542 in the second position (FIG.24C). The suture loop 552 can then be placed adjacent to theintermediate portion 536 of the suture retention member 528, and therelease pin 542 can be moved axially proximally through the suture loop552 (FIG. 25 ) and to the first position (FIG. 24A).

The ends (not shown) of the suture loop 552 can extend into and/orthrough the proximal portion 532 the suture retention member 528 and canbe secured to the proximal portion 532 (e.g., by an adhesive, knots,etc.).

Although not shown, it should be noted that, the delivery apparatus 500can comprise more than one suture loop 552 connecting the apices of thevalve frame to the release pin 542. For example, the delivery apparatus500 can have a suture loop 552 corresponding to some or all of theapices 120 of the prosthetic valve 102. In particular embodiments, thedelivery apparatus 500 has 12-15 suture loops 552. In some embodiments,a single suture loop can extend through or around more than one apex ofthe prosthetic valve. Desirably, all of the apices at the proximal endof the frame are connected to the release pin 542 by one or more sutureloops.

An assembly comprising the second portion 504 and a prosthetic valve 102connected to the second portion 504 by sutures 552 can be assembled bythe manufacturer and packaged in a sterile package for shipment to andstorage by the end user. The first portion 502 of the delivery apparatuscan be assembled by the manufacturer and packaged in a separate sterilepackage for shipment to and storage by the end user.

Referring now to FIGS. 22-23A, the delivery apparatus 500 can beassembled by the end user by coupling the second portion 504 to thedistal end of the first portion 502. This can be accomplished byinserting the proximal portion 532 of the suture retention member 528into the distal shaft 514 of the first catheter 506, as best shown inFIG. 23A. The distal shaft 514 can have one or more tabs 554 whichproject radially inward. The tabs 554 can engage an annular recessedportion 556 (FIG. 24B) of the proximal portion 532 of the sutureretention member 528. The tabs 554 can be configured to form a snap-fittype connection with proximal member 532 sufficient to secure the sutureretention member 528 to the distal shaft 514. The prosthetic valve 102can then be compressed and loaded into a sheath (e.g., by advancing thesheath distally over the prosthetic valve), which retains the prostheticvalve in a radially compressed state around the shaft 530.

The prosthetic valve 102 can be inserted into and advanced through apatient's body as described above. At or adjacent to the implantationsite, the sheath can be retracted to allow the prosthetic valve toself-expand. The prosthetic valve 102 can be released from the deliveryapparatus, for example, by distally advancing the guide-wire catheter508 relative to the implant delivery catheter 506 such that the push pin522 advances distally into and through the lumens 540 of the proximaland the distal portions 532, 534 of the suture retention member 528. Inthis manner, the push pin 522 pushes the release pin 542 axiallydistally from the first position to the second position, as best shownin FIG. 23B. As a result, the push pin 522 now extends through thesuture loop 552.

Alternatively, the push pin 522 and thus the release pin 542 can beadvanced distally such that the push pin 522 extends through the sutureloop 552 prior to loading the prosthetic valve 102 into the sheath. Theprosthetic valve 102 can then be loaded into the sheath and insertedinto a patient's body using the delivery apparatus 500.

Once inside the patient's body and the push pin 522 extending throughthe suture loop 552, the prosthetic valve 102 can be selectivelyreleased from the delivery apparatus 500 by proximally retracting theshaft 516 of the guide-wire catheter 508 relative to the implantdelivery catheter 506 such that a distal end of the push pin 522 isproximal to the intermediate portion 536 of the suture retention member528, as best shown in FIG. 23C. This can be accomplished, for example,by pulling on the guide-wire catheter 508 near the handle 510 whilemaintaining the positioning of the implant delivery catheter 506. Thisreleases the suture loop 552 from the push pin 522 and thus theprosthetic valve 102 from the delivery apparatus 500.

Configuring the delivery apparatus 500 such that a prosthetic valve canbe pre-mounted to the second portion 504, which can then be coupled tothe first portion 502 in a relatively easy manner can provide severalsignificant advantages. For example, the first portion 502 can bemanufactured and/or shipped separately from the assembly comprising thesecond portion 504 and the prosthetic valve and later assembled (e.g.,in an operating room). This can advantageously simplify and/or improvemanufacturing and/or logistical efficiency. It can also advantageouslyenable and/or improve modularity. For example, a physician caninterchange various prosthetic valves and/or delivery apparatusesrelatively easily to obtain the desired configuration.

FIGS. 26A-26C show an example of one embodiment a delivery apparatus600, which is similar to the delivery apparatus 500. As shown, thedelivery apparatus 600 can, for example, be a component of a deliveryassembly comprising a prosthetic valve (e.g., the prosthetic valve 102)and the delivery apparatus 600.

Referring to FIG. 26A, the deliver apparatus 600 can comprise a first,proximal portion 602 and a second, distal portion 604. The first andsecond portions 602, 604 can be separately formed, and the secondportion 604 can be coupled to the distal end of the first portion 602,as further explained below.

The first portion 602 of the delivery apparatus 600 can be configured ina manner similar to the first portion 502 of the delivery apparatus 500.As such, the first portion 602 can comprise a first catheter 606 (whichcan be referred to as an implant delivery catheter) and a secondcatheter 608 (which can be referred to as a guide-wire catheter)extending coaxially through the first catheter 608. The proximal ends ofthe catheters 606, 608 can extend to and/or be coupled to a handle 648.The catheters 606, 608 can be independently moveable (e.g., axiallyand/or rotatably) relative to each other. A separate sheath (not shownfor purposes of illustration) can extend over the first catheter 606 forretaining a prosthetic valve 102 in a compressed state for delivery.

The first catheter 606 can, for example, have a distal end portion 610formed from a slotted tube. The second catheter 608 can have an elongateguide-wire shaft 612 extending distally from the handle 648 and a pusherelement 614 which is connected to the distal end of the guide-wire shaft612. The pusher element 614 can have centrally radially disposed lumen(not show, but see lumen 520) and a push pin 616 disposed radiallyoutward from the lumen and extending distally from the distal surface ofthe pusher element 614. The lumen can have a radially tapered or funnelportion (not shown, but see funnel portion 524), which can help todirect a guide-wire (not shown) into a lumen (not shown, but see lumen526) of the guide-wire shaft 612 when the guide-wire is initiallyinserted into the delivery apparatus 600.

The second portion 604 of the delivery apparatus 600 can comprise asuture retention member 618 and a nose-cone shaft 620 connected to andextending distally from the suture retention member 618. The sutureretention member 618 can have a proximal portion 622, a distal portion624, a radially recessed intermediate portion 626 disposed between theproximal and distal portions 622, 624.

The second portion 604 can have a radially centrally disposed, firstlumen 628 which extends coaxially through the suture retention member618, the nose-cone shaft 620, and a nose cone 630 (which is connected tothe distal end of the nose-cone shaft 620). The second portion 604 canalso have a second lumen 632 which is disposed radially outward from thefirst lumen 628 and extends coaxially through the proximal and distalportions 622, 624 of the suture retention member 618 and through thenose cone 630.

The second portion 604 can have a release sleeve 634 which can beremovably disposed in the second lumen 632. The release sleeve 634 canbe axially moveable within the second lumen 632 between a fullyinserted, first position (e.g., FIG. 26A) and a fully removed, secondposition (e.g., FIG. 26C). As best shown in FIG. 26A, in the firstposition, a proximal end portion 636 of the release sleeve 634 isdisposed in the second lumen 632 and axially adjacent to the proximalportion 622 of the suture retention member 618. As shown in FIG. 26C, inthe second position, the release sleeve 634 has been moved axiallydistally such that the proximal end portion 636 is fully removed fromthe second lumen 632 (i.e., distal to the nose cone 630).

The release sleeve 634 can be configured to form a relatively snugtolerance fit within the second lumen 632 so that the release sleeve 634does not inadvertently slide out of the second lumen yet a user canremove the release sleeve 634 by pulling on a pull tab 638 at the distalend of the release sleeve with one hand while holding the nose cone 630with the other hand. The release sleeve 634 can also be configured suchthat the push pin 616 of the second catheter 604 can extend coaxiallythrough the release sleeve 634, as further described below.

A prosthetic valve can be releasably coupled to the second portion 604of the delivery apparatus 600 by sutures. For example, as shown, theprosthetic valve 102 can be releasably coupled to the second portion 604of the delivery apparatus 600 by a suture loop 640. The suture loop 640can extend radially through an aperture 122 of an apex 120 or around theapex 120 of the prosthetic valve 102, circumferentially around therelease sleeve 634 of the suture retention member 618, and back to theapex 120 of the prosthetic valve 102. The suture loop 640 can be wrappedaround the release sleeve 634 by positioning the release sleeve 634 suchthat the proximal end 636 of the release sleeve 634 is distal to theintermediate portion 626 of the suture retention member 618. The sutureloop 640 can then be placed adjacent to the intermediate portion 626,and the release sleeve 634 can be moved axially proximally through thesuture loop 640 and to the first position, as shown in FIG. 26A.

Although not shown, it should be noted that, the delivery apparatus 600can comprise more than one suture loop 640 connecting the apices 120 ofthe prosthetic valve 102 to the release sleeve 634. For example, thedelivery apparatus 600 can have a suture loop 640 corresponding to someor all of the apices 120 of the prosthetic valve 102. In particularembodiments, the delivery apparatus 600 has 12-15 suture loops 640.

In particular embodiments, the prosthetic valve 102 can be pre-attachedto the second portion 604 and packaged together in a sterile packageseparate from the first portion 602, which can be shipped and stored ina respective sterile package.

Referring now to FIGS. 26A-26B, the delivery apparatus 600 can beassembled (e.g., by the end user) by coupling the second portion 604 tothe distal end of the first portion 602. This can be accomplished, forexample, by inserting a distal end 642 of the push pin 616 into thesecond lumen 632 and the release sleeve 634 and by inserting theproximal portion 622 of the suture retention member 618 into the distalshaft 610 of the first catheter 606, as shown in FIG. 26B. The distalshaft 610 can have one or more tabs 644 which project radially inward.The tabs 644 can engage an annular recessed portion 646 (FIG. 26A) ofthe proximal portion 622 of the suture retention member 618. The tabs644 can be configured to form a snap-fit type connection with proximalmember 622 sufficient to secure the suture retention member 618 to thedistal shaft 610. The push pin 616 is advanced distally through therelease sleeve 634 until a distal end 646 of the push pin 616 is axiallyadjacent to the distal portion 624 of the suture retention member 618.

Prior to loading the prosthetic valve 102 into a sheath, the releasesleeve 634 can be removed from the second lumen 632 by distallyadvancing the release sleeve 634 to the second position by pulling onthe pull tab 638, thus leaving the push pin 616 extending axiallythrough the suture loops 640, as shown in FIG. 26C. The prosthetic valve102 can then be loaded into the sheath and inserted into a patient'sbody using the delivery apparatus 600.

Once inside the patient's body, the prosthetic valve 102 can beselectively released from the delivery apparatus 600 by proximallyretracting the guide-wire catheter 608 relative to the implant deliverycatheter 606 such that the distal end 642 of the push pin 616 isproximal to the intermediate portion 626 of the suture retention member618. This can be accomplished, for example, by pulling on the guide-wirecatheter 608 near the handle 648 while maintaining the positioning ofthe implant delivery catheter 606. This releases the suture loops 640from the push pin 616 and thus the prosthetic valve 102 from thedelivery apparatus 600.

FIGS. 27A-29 show an example of a delivery apparatus 700, according toone embodiment. As shown, the delivery apparatus 700 can, for example,be a component of a delivery assembly comprising a prosthetic valve(e.g., the prosthetic valve 102) and the delivery apparatus 700.

Referring to FIG. 27A, the deliver apparatus 700 can comprise a firstcatheter 702 (which can be called an implant delivery catheter), asecond catheter 704 (which can be called a guide wire catheter), asuture retention member 706, and a release shaft 708. The deliveryapparatus can also have a delivery cylinder 738 (FIG. 28A) which extendsover the catheters 702, 704. The proximal ends of the catheters 702, 704and the release shaft 708 can extend to and/or be coupled to a handle710 (FIG. 29 ). The suture retention member 706 can be secured orcoupled to the distal end of the first catheter 702. The second catheter704 can extend coaxially through the first catheter 702 and the sutureretention member 706. The release shaft 708 can extend axially throughthe first catheter 702 and the suture retention member 706 and can bedisposed radially outward (i.e., eccentric) from the second catheter704. The catheters 702, 704 and the release shaft 708 can beindependently moveable (e.g., axially and/or rotatably) relative to eachother.

The first catheter 702 can comprise an elongate distal end portion 712formed, for example, from a slotted tube to enhance the flexibility ofthe distal end portion 712 of the first catheter 702 in a manner similarto the first catheter 506.

Referring to FIG. 27A, the second catheter 702 can have an elongate nosecone shaft 714 at a distal end portion of the second catheter. A nosecone 716 can be connected to the distal end of the nose cone shaft 714.The second catheter 702 can have a guide wire lumen (not shown)extending coaxially through the nose cone shaft 714 and the nose cone716.

The suture retention member 706 can have a proximal portion 718, adistal portion 720, and a radially recessed intermediate portion 722disposed between the proximal and distal portions 718, 720. The sutureretention member 706 can have a radially centrally disposed, first lumen(not shown) through which the nose cone shaft 714 can extend. The firstlumen can extend coaxially through the proximal, intermediate, anddistal portions 718, 722, 720 of the suture retention member 706. Asbest shown in FIG. 27C, the suture retention member 706 can also have asecond lumen 724 which can be disposed radially outward from the firstlumen and the intermediate portion 722 and extend axially through theproximal and distal portions 718, 720.

As noted above, the suture retention member 706 can be secured ormounted to the distal end portion 714 of the first catheter 702 (e.g.,via a snap-fit connection). Additionally and/or alternatively, thesuture retention member 706 can be secured or coupled to the nose coneshaft 714. As such, the delivery apparatus 700 can be assembled as asingle unit and/or in a first, proximal portion and a second, distalportion which can be separately manufactured and later assembled (e.g.,in a manner similar to delivery apparatuses 500, 600).

The release shaft 708 can have a proximal end portion 726 extendingdistally from and/or disposed adjacent to the handle 710 (as shown inFIG. 29 ), a distal end portion 728 that is opposite from the proximalend portion 726, and an intermediate portion disposed between the endportions 726, 728. As noted above and best shown in FIGS. 27A-27C, therelease shaft 708 can be axially movable (i.e., proximally and distally)relative to the catheters 702, 704. For example, the release shaft 708can be positioned in a first, distal position in which the distal endportion 728 of the release shaft 708 extends into an opening 740 of thenose cone 716 (or extends adjacent to the nose cone 716), as best shownin FIG. 27A. From the first position, the release shaft 708 can beretracted proximally to a second, intermediate position in which thedistal end portion 728 of the release shaft 708 is disposed distal butrelatively close to the distal portion 720 of the suture retentionmember 706, as best shown in FIG. 27B. From the second position, therelease shaft 708 can be further retracted proximally to a third,proximal position in which the distal end portion 728 of the releaseshaft 708 is disposed proximal to the proximal portion 718 of the sutureretention member 706, as best shown in FIG. 27C. From the secondposition (FIG. 27B) and/or the third position (FIG. 27C), the releaseshaft 708 can be advanced distally to the first position (FIG. 27A). Therelease shaft 708 can also be axially movable to various otherpositions.

The distal end 728 of the release shaft 708 can be moved distally and/orproximally by moving the proximal end 726 of the release shaft 708distally and/or proximally relative to the catheters 702, 702 at oradjacent to the handle 710, which in turn causes the distal end 728 toaccordingly. In some embodiments, a release shaft positioning member 732can be adjustably coupled to the proximal end 726 of the release shaft706, as shown in FIG. 29 . The release shaft positioning member 732 canbe configured to engage the release shaft 708 so as to facilitate distaland/or proximal movement of the release shaft 708. For example, in oneparticular embodiment, the release shaft positioning member 732 cancomprise a rotatable knob 734 which cooperates with the release shaftpositioning member 732 to adjustably move the release shaft 708 distallywhen the knob 734 is rotated in a first direction (e.g.,counterclockwise) and to adjustably move the release shaft 708proximally when the knob 734 is rotated in a second, opposite direction(e.g., clockwise).

The release shaft 708 can be formed from various relatively flexible,yet resilient materials. For example, the release shaft 708 can beformed from nitinol, stainless steel, etc.

A prosthetic valve can be releasably coupled to the delivery apparatus700 by sutures. For example, as best shown in FIG. 27A, the outflow end114 of the prosthetic valve 102 (the proximal end of the prostheticvalve 102 in the illustrated embodiment) can be releasably coupled tosuture retention member 706 by one or more first suture loops 736 (e.g.,one shown in the illustrated embodiment). For purposes of illustration,FIGS. 27A-27C show only the frame 106 of the prosthetic valve 102. Theframe 106 is shown in FIGS. 27A-28B as being substantially cylindrical,however, it should be noted that the frame 106 can have a curved profileas shown in FIG. 3 .

Each of the first suture loop 736 can extend distally from the proximalportion 718 of the suture retention member 706, radially through and/oraround an apex 120 of the prosthetic valve 102, circumferentially aroundthe release shaft 708, and back to the apex 120 of the prosthetic valve102. Each of the first suture loop 736 can be wrapped around the releaseshaft 708 by positioning the distal end portion 728 of the release shaft708 proximal to the intermediate portion 722 of the suture retentionmember 706. The first suture loops 736 can each then be placed adjacentto the intermediate portion 722, and the distal end portion 728 of therelease shaft 708 can be advanced distally through the suture loop 736such that the distal end 728 portion of the release shaft 708 is disposeadjacent or distal to the distal portion 720 of the suture retentionmember 706. In this position, the outflow end 114 of the prostheticvalve 102 is releasably coupled to the delivery apparatus 700 via thefirst suture loops 736 (see, e.g., in the manner shown in FIG. 25 ). Asuture loop 736 can be used for each apex of the prosthetic valve, oralternatively, one suture loop 736 can be used for connecting multipleapices to the suture retention member 706.

The outflow end 114 of the prosthetic valve 102 can be released from thedelivery apparatus 700 by proximally retracting the distal end portion728 of the release shaft 708 relative to the catheters 702, 704 suchthat the distal end portion 728 is proximal to the intermediate portion722 of the suture retention member 706, as shown in FIG. 27C. Thisreleases the suture loop 736 from the release shaft 708 and thus theapex 120 of the prosthetic valve 102 from delivery apparatus 700.

The inflow end 110 of the prosthetic valve 102 (the distal end of theprosthetic valve 102 in the illustrated embodiment) can also bereleasably coupled to the delivery apparatus via one or more sutures.For example, in the illustrated embodiment, the prosthetic valve 102comprises a suture 190 (best shown in FIG. 27B) which extendscircumferentially around a waist portion 192 of the prosthetic valve 102to form a loop. The suture 190 can be secured or coupled to junctions orintersections 194 of the frame 106 of the prosthetic valve 102. Inalternative embodiments, the suture 190 can extend circumferentiallyaround and can be secured or coupled to the apices 118 of the prostheticvalve.

As best shown in FIG. 28B, the suture 190 can, for example, extendradially in and out of the frame 106 at the junctions 194 such thatfirst portions 190 a of the suture 190 are disposed radially outward andextend circumferentially over the junctions 194 of the frame 106 andsecond portions 190 b of the suture 190 are disposed radially inward andextend circumferentially between the junctions 194 of the frame 106. Asbest shown in FIG. 28A, one or more of the second portions 190 b of thesuture 190 can be pulled radially inward and wrapped around the releaseshaft 708, thus coupling inflow end 110 of the prosthetic valve 102 tothe delivery apparatus 700. This can be accomplished by positioning thedistal end 728 of the release shaft 708 proximal to the second portions190 b that are pulled radially inward and then distally advancing thedistal end portion 728 of the release shaft 708 through each of thesecond portions 190 b.

Although the illustrated embodiment shows four second portions 190 bwrapped around the release shaft 708, fewer or more second portions 190b can be wrapped around the release shaft 708. For example, there can be1-15 second portions 190 b that are wrapped around the release shaft708. Also, although the illustrated embodiment shows the second portions190 b pulled radially inwardly (e.g., forming internal loops which canbe wrapped around the release shaft 708), the second portions 190 b canbe pulled radially outwardly (e.g., forming external loops which can bewrapped around the release shaft 708).

The inflow end 110 of the prosthetic valve 102 can be released from thedelivery apparatus 700 by proximally retracting the distal end portion728 of the release shaft 708 relative to the catheters 702, 704 suchthat the distal end portion 728 is proximal to the second portions 190 bof the suture 190, as shown in FIG. 27B. This releases the secondportions 190 b from the release shaft 708 and thus the inflow end 110 ofthe prosthetic valve 102 from delivery apparatus 700.

The suture 190 can be configured such that the length of the suture 190is approximately the same as the circumference of the portion of theprosthetic valve to which the suture is coupled (e.g., the waist portion192 or the apices 118) when that portion of the prosthetic valve 102 isfully radially expanded. As such, in the fully radially expanded state(FIG. 28B), the suture 190 can be relatively taut yet allow theprosthetic valve to fully radially expand.

In this manner, the suture 190 and the delivery apparatus 700 can beused to control the radially expansion of inflow end 110 of theprosthetic valve 102. For example, the inflow end 110 can be at leastpartially radially compressed by pulling one or more of the secondportions 190 b of the suture 190 radially inwardly. This effectivelyforeshortens the circumferential length of the suture 190 and thusreduces the diameter of the loop formed by the suture 190. As a result,the first portions 190 a of the suture 190 can exert a radiallycompressive force on the waist portion 192 of the prosthetic valve 102which can cause the waist portion 192 to at least partially radiallycompress. Pulling the second portions 190 b farther radially inwardand/or pulling additional second portions 190 b of the suture 190radially inward can cause the waist portion 192 of the prosthetic valve102 to further radially compress; whereas releasing the second portions190 b can allow the prosthetic valve 102 to radially expand (due to theself-expanding nature of the prosthetic valve 102).

As best shown in FIG. 28A, the inflow end 110 of the prosthetic valve102 can be releasably secured in a radially compressed state by wrappingthe second portions 190 b of the suture 190 that are pulled radiallyinwardly around the distal end portion 728 of the release shaft 708.FIG. 28A, for example, shows four second portions 190 b that arereleasably secured radially inward by the distal end portion 728 of therelease shaft 708. As such, when the prosthetic valve 102 is deployedfrom a delivery cylinder 738, the inflow end 110 of the prosthetic 102can partially radially expand until the second portions 190 b of thesuture become taut against the distal end portion 728 of the releaseshaft 708. Thus, the release shaft 708 prevents the second portions 190b and thus the inflow end 110 of the prosthetic valve 102 from fullyexpanding radially outwardly.

In the partially radially expanded state, the inflow end 110 of theprosthetic valve 102 can expand far enough that the valve structure 108can begin functioning (e.g., the leaflets can open and close) andallowing at least some blood to flow through the valve structure 108 yetnot so far that it completely blocks blood flow around the prostheticvalve 102. Allowing blood to flow through and/or around the prostheticvalve 102 can advantageously allow a physician to assess the valvepositioning and/or make any desired adjustments without pressure againstthe prosthetic valve from the blocked blood flow causing the prostheticvalve to migrate to an undesired location. As a result, this can alsoadvantageously reduce and/or eliminate the need for rapid pacing of theheart to stop or slow blood flow, which is typically used to stop orslow blood flow to minimize undesired migration of a prosthetic valveduring an implantation procedure.

When the prosthetic valve 102 is desirably positioned, the inflow end110 of the prosthetic valve 102 can be fully radially expanded byproximally retracting the distal end portion 728 of the release shaft708 relative to the catheters 702, 704 such that the distal end portion728 is proximal to the second portions 190 b of the suture 190, as shownin FIG. 27B. This releases the second portions 190 b from the releaseshaft 708 and thus allows the inflow end 110 of the prosthetic valve 102to fully radially expand, as shown in FIG. 27B.

It should be noted that in this configuration (FIG. 27B), the prostheticvalve 102 can be retrieved and radially compressed into the deliverycylinder 738 because the sutures 736 remain coupled to the outflow end114 of the prosthetic valve 102. This can be accomplished by proximallyretracting the prosthetic valve into the delivery cylinder 738 and/ordistally advancing the delivery cylinder 738 over the prosthetic valve102. Once the desired positioning is achieved, the outflow end 114 ofthe prosthetic valve 102 can be released from the delivery apparatus 700by proximally retracting the release shaft 708 (FIG. 27C), as describedabove.

FIGS. 30A-34 show an example of a delivery apparatus 800, according toone embodiment. As best shown in FIG. 30A, the delivery apparatus 800can, for example, be a component of a delivery assembly comprising aprosthetic valve (e.g., the prosthetic valve 102) and the deliveryapparatus 800.

For purposes of illustration only the frame 106 of the prosthetic valve102 is shown. Although the frame 106 is shown as being substantiallycylindrical, it should be noted that the frame 106 can be curved in themanner shown in FIG. 3 .

Referring still to FIG. 30A, the deliver apparatus 800 can comprise afirst catheter 802 (which can be referred to as an implant deliverycatheter) extending coaxially through a delivery cylinder 804, a secondcatheter 806 extending coaxially through the first catheter 802, asuture retention member 808 secured or coupled to a distal end of thefirst catheter 802, a guide-wire catheter 810 extending coaxiallythrough the catheters 802, 806 and the suture retention member 808, anda release suture or wire 812 extending coaxially through the catheters802, 806 and the delivery cylinder 804 and axially adjacent to theguide-wire catheter 810. The proximal ends of the catheters 802, 806,810 and the release wire 812 can extend to and/or be coupled to a handle814. The catheters 802, 806, 810, the delivery cylinder 804, and therelease wire 812 can be independently moveable (e.g., axially and/orrotatably) relative to each other.

The first catheter 802 can comprise an elongate distal end portion 816.Although not shown, the distal end portion 816 can be formed, forexample, from a slotted tube to enhance the flexibility of the distalend portion 816 of the first catheter 802 in a manner similar to thefirst catheter 506.

The delivery cylinder 804 can be configured to cooperate with thecatheters 802, 806 similar to the manner in which the delivery cylinder128 cooperates with the catheters 124, 126. Although not shown, thesecond catheter 806 can comprise a threaded member or screw which iscoupled to a distal end of a rotatable torque shaft and is connected tothe delivery cylinder 804 via a nut (e.g., in the manner shown in FIGS.6A-6C).

The suture retention member 808 can comprise a proximal portion 818, adistal portion 820, a radially recessed intermediate portion 822disposed between the proximal and distal portions 818, 820, a pluralityof elongate tubes or sleeves 824 coupled or secured to and extendingdistally from the distal portion 820, and a plurality of sutures 826. Asnoted above, the proximal portion 818 of the suture retention member 808can be coupled or secured the distal end portion 816 of the firstcatheter 802 (e.g., via a snap-fit connection).

Referring now to FIGS. 31A-32 , the suture retention member 808 can havea radially centrally disposed, first lumen 828. The first lumen 828 canextend coaxially through the proximal, intermediate, and distal portions818, 822, 820 of the suture retention member 808. Although not shown,the first lumen 828 can allow the guide-wire catheter 810 to extendcoaxially through the suture retention member 808. The suture retentionmember 808 can also have a plurality of circumferentially spaced, secondlumens 830 (e.g., four in the illustrated embodiment) which can bedisposed radially outward from the first lumen 828 and extend axiallythrough the proximal and distal portions 818, 820 of the sutureretention member 808. The sutures 826 can extend through respectivesecond lumens 830, as further described below.

The distal portion 820 of the suture retention member can comprise oneor more annular portions or disks. In the illustrated embodiment, thedistal portion 820 has two annular portions 820 a, 820 b (collectivelyreferred to herein as the “distal portion 820”) which are axially spacedapart from each other, as best shown in FIG. 31B. In some embodiments,the distal portion 820 can have one annular portion. The distal portion820 can have a plurality of circumferentially spaced, openings 832(e.g., 12 in the illustrated embodiment) which can be disposed radiallyoutward from the lumens 828, 830 and extend axially through the distalportion 820 of the suture retention member 808, as best shown in FIG.31A. The openings 832 of the distal portion 820 can each be configuredto receive a proximal end portion 834 of a respective sleeve 824, asbest shown in FIG. 31B. The proximal end portions 834 of the sleeves 824can be secured within the respective openings 832 of the distal portion820, for example, by an adhesive and/or welding.

Referring again to FIG. 30A, each of the sleeves 824 can extend distallyfrom the proximal end portion 834 to a distal end portion 836. Each ofthe sleeves 824 can comprise an intermediate portion 838 which curves orflares radially outwardly such that the distal end portion 836 of thesleeve 824 is disposed radially outward from the proximal end portion834 of the sleeve 824. The intermediate portions 838 can be configuredto curve or flare radially outwardly such that the distal end portions836 are substantially radially aligned with the apices 120 of theprosthetic valve 102 when the prosthetic valve is fully radiallyexpanded. This can advantageously allow the prosthetic valve to fullyradially expand when the prosthetic valve 102 is deployed from thedelivery cylinder 804 and also allow the prosthetic valve to beretrieved into the delivery cylinder 804, as further described below.

The sleeves 824 can be formed from various suitable flexible, elasticmaterials. In some embodiments, for example, the sleeves can be formedfrom a super elastic and/or shape memory material or materials such asPoly ether ketone (“PEEK”) and/or nitinol. In one particular embodiment,the sleeves 824 are formed from nitinol tubes having an outer coveringformed from PEEK. In some embodiments, the sleeves 824 can have afriction-reducing coating and/or surface treatment applied to them.

As such, the sleeves 824 can be configured to be radially compressiblefrom a radially expanded configuration or state (e.g., FIG. 30A) to aradially compressed configuration or state (e.g., FIG. 30C). The sleeves824 can be radially compressed from the radially expanded state, forexample, by proximally retracting the first catheter 802 relative to thedelivery cylinder 804 and/or by distally advancing the delivery cylinder804 relative to the first catheter 802 such that the sleeves aredisposed within and retained in the radially compressed state by thedelivery cylinder 804, as best shown in FIG. 30C. The sleeves 824 can beradially expanded from the radially compressed state to the radiallyexpanded state, for example, by distally advancing the first catheter802 relative to the delivery cylinder 804 and/or by proximallyretracting the delivery cylinder 804 relative to the first catheter 802such that the sleeves are deployed from within the delivery cylinder804. As the sleeves 824 are deployed from the delivery cylinder 804, thesleeves 824 can expand radially outwardly as best shown in FIGS. 30B and30A.

As best shown in FIG. 33 , the distal end portion 836 of each sleeve 824can have a receiving element or cup 840 coupled and/or secured to thedistal tip of the sleeve 824. In some embodiments, a sleeve 824 and arespective cup 840 can be integrally formed from a single, unitary pieceof material. In other embodiments, a sleeve and a respective cup 840 canbe formed from separate pieces of material that are coupled to eachother (e.g., by an adhesive and/or welding). As also best shown in FIG.33 , the cups 840 can be configured to receive a respective apex 120 ofthe prosthetic valve 102.

The prosthetic valve 102 can be releasably coupled to the deliveryapparatus 800 via releasable suture loops formed by the sutures 826. Thesuture loops can be formed, for example, by securing first ends 842 ofthe sutures 826 to a proximal end of the distal portion 820 of thesuture retention member 808 at or adjacent to the openings 832. This canbe accomplished, for example, by tying the first end 842 of one suture826 to the first end 842 of one or more other sutures 826. For example,FIG. 31A shows each of the first ends 842 of the sutures tied to thefirst end 842 of one other suture 826 (i.e., forming six pairs). Thefirst ends 842 can be secured to the suture retention member and/or toeach other in various other ways such as by an adhesive.

From the proximal end of the distal portion 820, each suture 826 canextend distally into and through a respective opening 832 and/or intoand through a respective sleeve 824, as best shown in FIGS. 31A and 33 .The sutures 826 can extend out of a respective sleeve 824 and extendthrough (e.g., via an opening 122) and/or around a respective apex 120at the outflow end 114 of the prosthetic valve 102, as best shown inFIGS. 30A and 33 .

The sutures 826 can then extend proximally (and slightly radiallyinward) back to the distal portion 820 of the suture retention member808, as best shown in FIGS. 30A and 32 . The sutures 826 can extenddistally into and through a respective second lumen 830 of the sutureretention member 808 (e.g., three sutures 826 in each second lumen 830)and second ends 844 of the sutures 826 can exit the respective secondlumens 830 at the proximal end of the proximal portion 818, as bestshown in FIGS. 31A-31B.

The apices 120 of the prosthetic valve 102 can then be positioned in thecups 840 of the sleeves 824 by tensioning the second ends 844 thesutures 826, which causes the apices 120 to move proximally toward andinto the cups 840, as best shown in FIG. 33 . The second ends 844 of thesutures 826 can then be releasably secured to each other and/or to therelease wire 812. For example, FIG. 34 shows a first suture 826 a tiedto a second suture 826 b and to a first loop 812 a of the release wire812 by a releasable knot. The knot can be unraveled by tensioning therelease wire 812 which causes the first loop 812 a to pull the secondend 844 of the first suture 826 a out of the knot, which allows the knotto unravel. Although not shown, the second suture 826 b can also bereleasably secured to the release wire 812 (e.g., by a second loop 812 b(FIG. 31B).

In this manner, the delivery apparatus 800 can be used to deploy and/orretrieve the prosthetic valve 102 in an implantation site in a patient'sbody. For example, with the prosthetic valve 102 radially compressed andretained within the delivery cylinder 804, the prosthetic valve 102 canbe advanced to or adjacent to an implantation site. The prosthetic valve102 can then be deployed by distally advancing the first catheter 802relative to the delivery cylinder 804 and/or by proximally retractingthe delivery cylinder 804 relative to the first catheter 802, which canallow the prosthetic valve to radially expand. In the radially expandedstate, the prosthetic valve 102 can be positioned, retrieved, and/orreleased from the delivery apparatus 800.

The prosthetic valve 102 can be positioned by moving the first catheter802 axially, rotationally, etc. which in turn causes correspondingmovement of the prosthetic valve 102.

The prosthetic valve 102 can be retrieved by proximally retracting thefirst catheter 802 relative to the delivery cylinder 804 and/or bydistally advancing the delivery cylinder 804 relative to the firstcatheter 802. This causes the sleeves 824 of the suture retention member808 to radially compress as the sleeves 824 retract proximally into thedelivery cylinder 804, which in turn causes the apices 120 of theprosthetic valve 102 to radially compress retract proximally into thedelivery cylinder 804 together with the sleeves 824. As such, thesleeves 824 can guide the apices 120 of the prosthetic valve 102 intothe delivery cylinder 804. This can advantageously prevent the apicesfrom snagging on the end of the delivery cylinder and/or significantlyreduce the amount of force that is needed to retrieve the prostheticvalve 102 into the delivery cylinder 804. For example, in someembodiments, the delivery apparatus 800 requires about forty percentless force to retrieve a prosthetic valve into a delivery cylinder thana delivery apparatus without sleeves (e.g., the sleeves 824) and/ortension-able sutures.

The prosthetic valve 102 can be released from the delivery apparatus 800by unraveling the knots in the second ends 844 of the sutures 826 bypulling the release wire 812 proximally relative to the suture retentionmember 808, as described above. With the second ends 844 free, the firstcatheter 802 and thus the suture retention member 808 can be proximallyretracted relative to the prosthetic valve 102. This allows the cups 840of the sleeves 824 to move proximally and separate from the apices 120of the prosthetic valve 102, as shown in FIG. 30A. As the first catheter802 is farther proximally retracted, the second ends 844 of the suturesretract from the second lumens 830 of the sutures retention member 808and from the apices 120 of the prosthetic valve 102, thus releasing theprosthetic valve 102 from the delivery apparatus 800.

FIGS. 35-43 show an exemplary embodiment of a delivery assembly 900 andits components. Referring to FIG. 35 , the delivery assembly 900 cancomprise two main components: a prosthetic heart valve 902 and adelivery apparatus 904. To better illustrate a releasable couplingbetween the prosthetic heart valve 902 and the delivery apparatus 904,only an annular frame 910 of the prosthetic heart valve 902 is shown.The prosthetic heart valve 902 can, however, comprise various othercomponents (e.g., a valve structure) and can be configured similar tothe prosthetic heart valve 102. The prosthetic heart valve 902 can bereleasably coupled to a distal end portion 906 of the delivery apparatus904 with a plurality of suture loops 908, as further explained below.

Referring to FIG. 36 , the frame 910 of the prosthetic heart valve 902can comprise an outflow end portion 912 and an inflow end portion 914.The frame 910 can include a plurality of struts 916 forming first andsecond pluralities of apices 918, 920 at the outflow and inflow endportions 912, 914 of the frame 910, respectively. The frame 910 can alsoinclude a plurality of attachment structures 922 (e.g., three in theillustrated embodiment) that are coupled to at least some of the apices918 of the outflow end portion 912. The attachment structures 922 (e.g.,eyelets) can comprise openings 924 formed therein. As shown in FIG. 35 ,the apices 918 and the attachment structures 922, in combination withthe suture loops 908, can be used to releasably couple the prostheticheart valve 902 to the delivery apparatus 904, as further explainedbelow.

In some embodiments, the attachment structures 922 can be evenlydistributed circumferentially on the outflow end portion 912 of theframe 910. As shown in FIG. 36 , for example, the outflow end portion912 comprises 15 apices 918 and three attachment structures 922. Theattachment structures 922 are evenly distributed around the outflow endportion 912 such that there are four apices 918 between each adjacentattachment structure 922. In other embodiments, the frame 910 cancomprise more or fewer apices 918 and/or attachment structures 922,and/or the attachment structures 922 can be non-evenly distributedaround the outflow end portion 912. In some embodiments, the frame 910can have an attachment structure 922 at each apex 918.

Referring to FIG. 37 , the delivery apparatus 904 can comprise a firstcatheter 926, a second catheter (not shown), a nose-cone catheter 928,and a delivery cylinder or sheath 930 (FIG. 40 ), a suture guide 932,the suture loops 908 (e.g., 12 in the illustrated embodiment, see FIG.35 ), a plurality of apex guides 934 (e.g., three in the illustratedembodiment), and one or more attachment members or tethers 936 (e.g.,three in the illustrated embodiment). The first catheter 926, secondcatheter, nose-cone catheter 928, and delivery cylinder 930 of thedelivery apparatus 904 can be configured similar to the catheters 124,126, 128 and the delivery cylinder 150 of the delivery apparatus 104,respectively.

Referring to FIG. 38 , the suture guide 932 can comprise a proximalportion 938, an intermediate portion 940, and a distal portion 942. Thesuture loops 908 can be coupled to the proximal portion 938 of thesuture guide 932 (e.g., with knots, adhesive, etc.). The proximalportion 938 of the suture guide 932 can be coupled (e.g., snap fit) to adistal end portion 944 of the first catheter 926, as shown in FIG. 37 .

Referring to FIG. 43 , the apex guides 934 can comprise one or moreopenings 946 (four in the illustrated embodiment. The openings 946 caneach be configured to receive one or more of the suture loops 908 and/orthe tethers 936. For example, as shown in FIG. 38 , each of the sutureloops 908 can be threaded through a respective opening 946 of the apexguides 934. As such, the apex guides 934 can move (e.g., slide) relativeto the suture loops 908. It should be noted that FIG. 38 shows only oneapex guide 934 and four suture loops 908 for purposes of illustration.

In some embodiments, the suture loops 908 can comprise one or morestopper members 948 configured to prevent the apex guides 934 frommoving toward fixed end portions 950 of the suture loops 908. Forexample, in the illustrated embodiment, the two outer-most suture loops908 that extend through each of the sutures guides 934 each have astopper member 948. The stopper members 948 comprise knots formed in thesuture loops 908, ferrules, beads, and/or other objects that are crimpedand/or otherwise coupled to the suture loops 908. The stopper members948 do not, however, prevent the apex guides 934 from moving toward freeend portions 952 of the suture loops 908.

Referring again to FIG. 37 , the apex guides 934 can, for example, becoupled to the suture guide 932 with the tethers 936. The tethers 936can keep the apex guides 934 attached to the delivery apparatus 904 whenthe prosthetic heart valve 902 is released from the delivery apparatus904 by retracting the suture loops 908 from the apices 918 andattachment structures 922 of the prosthetic heart valve 902. The tethers936 can, for example, extend through the inner-most openings 946 of arespective apex guide 934. In other embodiments, the tethers 936 can becoupled to an additional or different component of the deliveryapparatus (e.g., the distal end portion 944 of the first catheter 926).

The apex guides 934 can have a generally curved or bean-shape, as shownin the illustrated embodiment. As such, the apex guides 934 collectivelycan form an annular ring having an outer diameter similar to the innerdiameter of the delivery cylinder 930 when the apex guides 934 aredisposed adjacent and contacting each other in an array, as best shownin FIG. 41 . The array of apex guides 934 can also have an innerdiameter that is configured to allow components (e.g., the nose-conecatheter 928 to extend therethrough. In other embodiments, the apexguides 934 can comprise various other shapes, including cylindrical,ovular, rectangular, etc.

Referring again to FIG. 35 , the prosthetic heart valve 902 can beattached to the delivery apparatus 904, for example, by wrapping thefree end portions 952 of each of the suture loops 908 around arespective apex 918 of the prosthetic heart valve 902 that does not havean attachment structure 922. The free end portions 952 can then bethreaded through respective, adjacent attachment structures 922 of theprosthetic heart valve 902. As such, each of the attachment structures922 has four suture loops 908 extending therethrough (i.e., two sutureloops 908 from each of the two adjacent apex guides 934). The free endportions 952 of the suture loops 908 can then extend radially inwardtoward the intermediate portion 940 of the suture guide 932. The freeend portions 952 can be releasably secured to relative to the prostheticheart valve 902 and the suture guide 932 via one or more release pins954 that extend from the proximal portion 938 of the suture guide 932,adjacent the intermediate portion 940 of the suture guide 932 andthrough the suture loops 908, and to the distal portion 942 of thesuture guide 932 (e.g., similar to the manner shown in FIG. 25 ).

FIGS. 39-42 illustrate the delivery apparatus 904 retrieving theprosthetic heart valve 902 into the delivery cylinder 930. FIG. 39 showsthe prosthetic heart valve 902 fully deployed from the delivery cylinder930. In this configuration, the apex guides 934 are disposed on therespective suture loops 908 between the stopper members 948 and theapices 918 of the prosthetic heart valve 902. Referring to FIG. 40 , asthe delivery cylinder 930 and the prosthetic heart valve 902 are movedtoward each other (e.g., by advancing the delivery cylinder 930 distallyrelative to the prosthetic heart valve 902 and/or retracting theprosthetic heart valve 902 proximally relative to the delivery cylinder930), the suture loops 908 are drawn into the delivery cylinder 930, andthe apex guides 934 abut the distal end 956 of the delivery cylinder930. Referring to FIG. 41 , the suture loops 908 then slide relative tothe apex guides 934 drawing the apices 918 toward the apex guides 934and the distal end 956 of the delivery cylinder 930 until the apices 918contact the apex guides 934. The apex guides 934 then pivot about thedistal end 956 of the delivery cylinder 930 from the orientation shownin FIG. 40 (i.e., with smaller radial curves 958 of the apex guides 934directed generally distally) to the orientation shown in FIG. 41 (i.e.,with the smaller radial curves 958 of the apex guides 934 directedgenerally inwardly) and then to the orientation shown in FIG. 42 (i.e.,the orientation in which the smaller radial curves 958 of the apexguides 934 directed generally proximally). As the apex guides 934 pivot,the apices 918 slide along the inner surfaces of the apex guides 934 andare drawn into the delivery cylinder 930 without snagging on the distalend 956 of the delivery cylinder 930.

FIGS. 44-45 show exemplary embodiments of apex guides 1000, 1100, whichcan be used in lieu of or in addition to the apex guides 934. The apexguide 1000 is similar to the apex guides 934 but comprises a singlearcuate slit 1002 rather than the openings 924. The apex guide 1100comprises a plurality of openings 1102 and an elongate slit 1104. Insome embodiments, a tether 936 can be looped through the openings 1102,and the suture loops 908 can extend through the slit 1104.

FIG. 46-47 show an attachment member 1200 that can be used in lieu of orin addition to the tethers 936. As best shown in FIG. 46 , theattachment member 1200 comprises a hub 1202, a plurality of legs 1204(e.g., three in the illustrated embodiment), and a central opening 1204.The legs 1204 can extend outwardly from the hub 1202. The apex guides932 can be coupled to the legs 1204 (e.g., molded or with an adhesive).The central opening 1206 can extend through the hub 1202 and can beconfigured to receive the intermediate portion 940 of the suture guide932, as shown in FIG. 47 . The attachment member 1200 can be formed ofvarious elastomeric materials, such as polyurethane, polyether blockamide, and/or silicone, to name a few.

FIGS. 48-52 show an exemplary embodiment of a delivery apparatus 1300.The delivery apparatus 1300 can be used, for example, with theprosthetic heart valve 902. Referring to FIG. 48 , the deliveryapparatus 1300 can comprise a suture guide 1302, a plurality of sutureloops 1304 (e.g., 12 in the illustrated embodiment), a plurality of apexguides or petals 1306 (e.g., 12 in the illustrated embodiment), and adelivery cylinder 1308 (FIG. 50 ). The suture loops 1304 can extendthrough and couple the apex guides 1306 to the suture guide 1302, andthe apex guides 1306 can prevent or reduce the likelihood of the apices918 of the prosthetic heart valve 902 of snagging or on a deliverycylinder 1308 of the delivery apparatus 1300.

The suture guide 1302 can be configured similar to the suture guide 932of the delivery apparatus 904 and can be coupled to a distal end of acatheter shaft. The suture guide 1302 can comprise a proximal portion1310, an intermediate portion (not shown), and a distal portion (notshown). The suture loops 1304 can be coupled to and extend from theproximal portion 1310 of the suture guide 1302.

Referring to FIG. 49 , the apex guides 1306 can each include a proximalend portion 1312, a distal end portion 1314, a first opening 1316, asecond opening 1318, and a third opening 1320. The first opening 1316can be formed in the proximal end portion 1312, the third opening 1320can be formed in the distal end portion 1314, and the second opening1318 can be formed in apex guide 1306 between the first and thirdopenings 1316, 1320. In some embodiments, the proximal end portion 1312can be relatively narrower than the distal end portion 1314.

The apex guides 1306 can comprise a length L and a width W. The length Lcan be sized and configured such that the apex guides 1306 do notprevent the outflow end portion 912 of the prosthetic heart valve 902from fully radially expanding when the prosthetic heart valve 902 andthe apex guides 1306 are fully deployed from the delivery cylinder 1308(e.g., FIG. 50 ). The width W can be sized such that each apex guide1306 is circumferentially spaced apart relative to an adjacent apexguide 1306 when the prosthetic heart valve 902 and the apex guides 1306are fully deployed from the delivery cylinder 1308 (e.g., FIG. 50 ).

In some embodiments, for example, the length L can be 0.2-0.5 in. (5-13mm) and the width W can be 0.07-0.14 in. (1.5-4 mm). In particularembodiments, the length L can be 0.315-0.380 in. (8-9.65 mm), and thewidth W can be 0.094-0.110 in. (2.39-2.79 mm). In one specificembodiment, a apex guide 1306 having a length L of 0.315 in. (8.00 mm)and a width W of 0.094 in. (2.39 mm) can be used with a prosthetic heartvalve 902 having a nominal outer diameter of 0.91 in (23 mm). In anotherspecific embodiment, a apex guide 1306 having a length L of 0.35 in.(8.89 mm) and a width W of 0.105 in. (2.67 mm) can be used with aprosthetic heart valve 902 having a nominal outer diameter of 1.02 in.(26 mm). In yet another specific embodiment, a apex guide 1306 having alength L of 0.38 in. (9.65 mm) and a width W of 0.110 in. (2.79 mm) canbe used with a prosthetic heart valve 902 having a nominal outerdiameter of 1.14 in. (29 mm).

The apex guides 1306 can comprise a relatively thin, flat shape and canbe formed from various thin, flexible materials including any of varioussuitable biocompatible polymers and metals. For example, the apex guides1306 can be formed from polyester, PEEK, polycarbonate, stainless steel,nitinol, cobalt chromium, and/or other thin flexible material.

Referring again to FIG. 48 , each of the apex guides 1306 can be coupledto the suture guide 1302 by threading a respective suture loop 1304through the first opening 1316 of the apex guide 1306 from a radiallyoutwardly facing surface 1322 of the apex guide 1306 (i.e., the surfacefacing away from the prosthetic heart valve 902 as illustrated in FIG.48 ) to a radially inwardly facing surface of the apex guide 1306. Thesuture loop 1304 can then extend along the radially inwardly facingsurface from the first opening 1316 to the second opening 1318 and canpass through the second opening 1318 to the radially outwardly facingsurface 1322. The suture loop 1304 can then extend along the radiallyoutwardly facing surface 1322 from the second opening 1318 to the thirdopening 1320 and can pass through the third opening 1320 to the radiallyinwardly facing surface.

The prosthetic heart valve 902 can then be coupled to the deliveryapparatus 1300 by wrapping free end portions 952 (e.g., similar to thefree end portions 952 FIG. 38 ) of each suture loop 1304 around arespective apex 918 of the prosthetic heart valve 902 that does not havean attachment structure 922. The free end portions of the suture loops1304 can then be threaded through respective, adjacent attachmentstructures 922 of the prosthetic heart valve 902. As such, each of theattachment structures 922 has four suture loops 1304 extendingtherethrough (i.e., two suture loops 1304 from each of the two adjacentapices 918). The free end portions then extend radially inwardly towardthe intermediate portion of the suture guide 1302. The free ends of thesuture loops 1304 can be releasably secured to relative to theprosthetic heart valve 902 and the suture guide 1302 via one or morerelease pins (e.g., similar to release pin 542 of the delivery apparatus500 shown in FIG. 25 ).

FIGS. 50-52 show the prosthetic heart valve 902 being retrieved into thedelivery cylinder 1308. As mentioned above, FIG. 50 shows the prostheticheart valve 902 and the apex guides 1306 fully deployed from thedelivery cylinder 1308. Referring to FIG. 51 , as the delivery cylinder1308 and the prosthetic heart valve 902 are moved toward each other(e.g., by advancing the delivery cylinder 1308 distally relative to theprosthetic heart valve 902 and/or retracting the prosthetic heart valve902 proximally relative to the delivery cylinder 1308), the suture loops908 and the proximal end portions 1312 of the apex guides 1306 are drawninto the delivery cylinder 1308. The distal end 1324 of the deliverycylinder 1308 contacts the radially outwardly facing surfaces 1322 ofthe apex guides 1306 and urges the apex guides 1306 radially inwardlyfrom a radially-extending orientation (e.g., FIG. 50 ) to anaxially-extending orientation (e.g., FIG. 51 ). This causes the outflowend portion 912 to radially compress, and the distal end portions 1314of the apex guides 1306 to circumferentially overlap, as shown in FIG.51 . Referring to FIG. 52 , the apices 918 of the prosthetic heart valve902 are then drawn into the delivery cylinder 1308 without snagging onthe distal end 1324 of the delivery cylinder 1308 because the apices 918are disposed on the radially inwardly facing surface of the apex guides1306, which can prevent direct contact between the apices 918 and thedistal end 1324 of the delivery cylinder 1308.

As described above, attaching a prosthetic heart valve to a deliveryapparatus with apex guides (e.g., the apex guides 934, 1000, 1100, 1306)can prevent (or reduce the likelihood of) apices and/or attachmentstructures from catching or snagging on a distal end of a deliverycylinder when the prosthetic heart valve is at least partially retrievedinto the delivery cylinder after being fully deployed from the deliverycylinder. This can, for example, make repositioning and/or retrievingthe prosthetic heart valve 902 significantly easier, quicker, and orrequire less force. It can also prevent or reduce damage to the deliveryapparatus (e.g., tearing the delivery cylinder).

These features can be particularly advantageous when there is a steepangle between a longitudinal axis of a delivery cylinder and alongitudinal axis of the prosthetic heart valve duringretrieval/repositioning of the prosthetic heart valve. A steep anglebetween the delivery cylinder and the prosthetic heart valve can becaused, for example, by the native anatomy of a patient. One particularexample of this is when a retrograde delivery path (i.e., through thepatient's aorta) is used for a transcatheter aortic valve implantation(“TAVI”), and the patient has a relatively short ascending aorta (e.g.,the distance from the native aortic annulus to the aortic arch isrelatively shorter than normal). This can result in a steep anglebetween the delivery cylinder and the deployed prosthetic heart valvebecause the sharp curve that the delivery apparatus has to make aroundthe aortic arch tends position the delivery cylinder non-coaxial to thenative aortic annulus in which the prosthetic heart valve is deployed.

It should be noted a delivery apparatus (e.g., the delivery apparatus904, 1300) and a prosthetic heart valve (e.g., the prosthetic valves102, 902) can be configured for various implantation locations and/ormethods. For example, although the delivery apparatus 904 is showncoupled to an outflow end portion 912 of the prosthetic heart valve 902(e.g., for retrograde TAVI), the delivery apparatus 904 can be coupledto the inflow end portion 914 of the prosthetic heart valve 902 (e.g.,for transventricular TAVI).

The technologies from any example can be combined with the technologiesdescribed in any one or more of the other examples. In view of the manypossible embodiments to which the principles of the disclosed technologymay be applied, it should be recognized that the illustrated embodimentsare only preferred examples and should not be taken as limiting thescope of the disclosed technology.

The invention claimed is:
 1. A method for delivering a prosthetic valveto a native annulus of a heart, comprising: inserting a deliveryapparatus into a patient's body; advancing the delivery apparatus to animplantation location within the native annulus; retracting a deliverysheath of the delivery apparatus relative to the prosthetic valve toexpose the prosthetic valve from a distal end of the delivery sheath;and after the prosthetic valve is exposed from the delivery sheath,expanding the prosthetic valve from a radially compressed state to aradially expanded state by reducing axial tension on a first end and asecond end of the prosthetic valve; wherein reducing the axial tensionon the first end of the prosthetic valve precedes reducing the axialtension on the second end of the prosthetic valve.
 2. The method ofclaim 1, wherein reducing the axial tension on the first end and thesecond end of the prosthetic valve comprises reducing the axial tensionon a plurality of sutures of the delivery apparatus.
 3. The method ofclaim 1, wherein reducing the axial tension on the first end and thesecond end of the prosthetic valve comprises moving a first manifold ofthe delivery apparatus axially proximally toward a second manifold ofthe delivery apparatus.
 4. A method for delivering a prosthetic valve toa native annulus of a heart, comprising: inserting a delivery apparatusinto a patient's body; advancing the delivery apparatus to animplantation location within the native annulus; retracting a deliverysheath of the delivery apparatus relative to the prosthetic valve toexpose the prosthetic valve from a distal end of the delivery sheath;and after the prosthetic valve is exposed from the delivery sheath,expanding the prosthetic valve from a radially compressed state to aradially expanded state by reducing axial tension on a first end and asecond end of the prosthetic valve; wherein reducing the axial tensionon the first end and the second end of the prosthetic valve comprisesmoving a first manifold of the delivery apparatus axially proximallytoward a second manifold of the delivery apparatus, and wherein theradially expanded state of the prosthetic valve is a first radiallyexpanded state, and the method further comprises expanding theprosthetic valve from the first radially expanded state to a secondradially expanded state by radially converging the first end and thesecond end of the prosthetic valve and axially compressing the first endand the second end of the prosthetic valve by moving the first manifoldof the delivery apparatus axially proximally toward the second manifoldof the delivery apparatus, wherein the prosthetic valve is radiallylarger in the second radially expanded state than in the first radiallyexpanded state.
 5. The method of claim 4, wherein reducing the axialtension on the first end of the prosthetic valve and reducing the axialtension on the second end of the prosthetic valve occur simultaneously.6. The method of claim 4, further comprising radially compressing theprosthetic valve by moving the first manifold of the delivery apparatusaxially distally away from the second manifold of the deliveryapparatus.
 7. A method for delivering a prosthetic valve to a nativeannulus of a heart, comprising: inserting a sheath of a deliveryapparatus into a patient's body, wherein a distal end portion of theprosthetic valve is releasably coupled to a first suture guide of thedelivery apparatus via one or more first sutures, wherein a proximal endportion of the prosthetic valve is releasably coupled to a second sutureguide of the delivery apparatus via one or more second sutures, andwherein the prosthetic valve, the first suture guide, and the secondsuture guide are disposed within the sheath; advancing the sheathtogether with the prosthetic valve to an implantation location withinthe native annulus; retracting the sheath to expose the prostheticvalve, the first suture guide, and the second suture guide from thesheath; and after the prosthetic valve, the first suture guide, and thesecond suture guide are exposed from the sheath, expanding theprosthetic valve from a radially compressed state to a radially expandedstate by moving the first suture guide and the second suture guidetoward each other; wherein after moving the first suture guide and thesecond suture guide toward each other, the method further comprisesreducing tension in the first sutures or the second sutures.
 8. Themethod of claim 7, wherein prior to moving the first suture guide andthe second suture guide toward each other, the method further comprisesreducing tension in the first sutures or the second sutures.
 9. Themethod of claim 7, wherein prior to moving the first suture guide andthe second suture guide toward each other, the method further comprisesreducing tension in the first sutures and the second sutures.
 10. Themethod of claim 7, wherein the first suture guide is coupled to a firstshaft of the delivery apparatus, wherein the second suture guide iscoupled to a second shaft of the delivery apparatus, and wherein thefirst shaft extends coaxially through the second shaft and the secondsuture guide.
 11. A method for delivering a prosthetic valve to a nativeannulus of a heart, comprising: inserting a sheath of a deliveryapparatus into a patient's body, wherein a distal end portion of theprosthetic valve is releasably coupled to a first suture guide of thedelivery apparatus via one or more first sutures, wherein a proximal endportion of the prosthetic valve is releasably coupled to a second sutureguide of the delivery apparatus via one or more second sutures, andwherein the prosthetic valve, the first suture guide, and the secondsuture guide are disposed within the sheath; advancing the sheathtogether with the prosthetic valve to an implantation location withinthe native annulus; retracting the sheath to expose the prostheticvalve, the first suture guide, and the second suture guide from thesheath; and after the prosthetic valve, the first suture guide, and thesecond suture guide are exposed from the sheath, expanding theprosthetic valve from a radially compressed state to a radially expandedstate by moving the first suture guide and the second suture guidetoward each other; wherein after moving the first suture guide and thesecond suture guide toward each other, the method further comprisesreducing tension in the first sutures and the second sutures.
 12. Amethod for delivering a prosthetic valve to a native annulus of a heart,comprising: inserting a sheath of a delivery apparatus into a patient'sbody, wherein a distal end portion of the prosthetic valve is releasablycoupled to a first suture guide of the delivery apparatus via one ormore first sutures, wherein a proximal end portion of the prostheticvalve is releasably coupled to a second suture guide of the deliveryapparatus via one or more second sutures, and wherein the prostheticvalve, the first suture guide, and the second suture guide are disposedwithin the sheath; advancing the sheath together with the prostheticvalve to an implantation location within the native annulus; retractingthe sheath to expose the prosthetic valve, the first suture guide, andthe second suture guide from the sheath; and after the prosthetic valve,the first suture guide, and the second suture guide are exposed from thesheath, expanding the prosthetic valve from a radially compressed stateto a radially expanded state by moving the first suture guide and thesecond suture guide toward each other; wherein the first suture guide iscoupled to a first shaft of the delivery apparatus, wherein the secondsuture guide is coupled to a second shaft of the delivery apparatus, andwherein the first shaft extends coaxially through the second shaft andthe second suture guide, and wherein the second suture guide comprises afirst lumen, a plurality of first openings, and a plurality of secondopenings, wherein the first openings and the second openings aredisposed radially outwardly relative to the first lumen, wherein thesecond openings are disposed radially outwardly relative to the firstopenings, wherein the first shaft extends through the first lumen of thesecond suture guide, wherein the first sutures extend through the firstopenings of the second suture guide, and wherein the second suturesextend through the second openings of the second suture guide.
 13. Amethod for delivering a prosthetic valve to a native annulus of a heart,comprising: inserting a sheath of a delivery apparatus into a patient'sbody, wherein a distal end portion of the prosthetic valve is releasablycoupled to a first suture guide of the delivery apparatus via one ormore first sutures, wherein a proximal end portion of the prostheticvalve is releasably coupled to a second suture guide of the deliveryapparatus via one or more second sutures, wherein the first sutures andthe second sutures are coupled to a tensioning member, and wherein theprosthetic valve, the first suture guide, and the second suture guideare disposed within the sheath; advancing the sheath together with theprosthetic valve to an implantation location within the native annulus;retracting the sheath to expose the prosthetic valve, the first sutureguide, and the second suture guide from the sheath; and after theprosthetic valve, the first suture guide, and the second suture guideare exposed from the sheath, expanding the prosthetic valve from aradially compressed state to a first radially expanded state by movingthe tensioning member distally relative to the first suture guide andthe second suture guide, wherein in the first radially expanded state,the prosthetic valve comprises a first length and a first diameter. 14.The method of claim 13, further comprising expanding the prostheticvalve from the first radially expanded state to a second radiallyexpanded state by moving the tensioning member proximally relative tothe first suture guide and the second suture guide and by moving thefirst suture guide and the second suture guide toward each other,wherein in the second radially expanded state, the prosthetic valvecomprises a second length and a second diameter, wherein the secondlength is less than the first length, and wherein the second diameter isgreater than the first diameter.
 15. The method of claim 14, wherein theprosthetic valve comprises a cylindrical shape in the first radiallyexpanded state.
 16. The method of claim 15, wherein the prosthetic valvecomprises a more spherical shape in the second radially expanded statethan the cylindrical shape in the first radially expanded state.
 17. Themethod of claim 16, wherein the first suture guide is coupled to a firstshaft, wherein the second suture guide is coupled to a second shaft,wherein the tensioning member is coupled to a third shaft, wherein thefirst shaft extends through the second shaft and the third shaft, andwherein the third shaft is disposed within the second shaft.
 18. Themethod of claim 17, wherein expanding the prosthetic valve from theradially compressed state to the first radially expanded state includesmoving the third shaft relative to the first shaft and the second shaft,and wherein expanding the prosthetic valve from the first radiallyexpanded state to the second radially expanded state includes moving thefirst shaft and the second shaft relative to the third shaft.